c0Nc rY TNHHcONc NGHE y rm s. crAo DUC peB

56: l lArtK_peB

CGNG HOA XA Uqlt CHU ruq;rgi,,,q 1--t[,"i -",','i{DQc l$g] - Ty do - H*nlr ph{:c

Tp Hd Nii. ngr)1, l4 rltin;1ti7 *r.'n: ,:!i!'"

TAI LIEU KY THUAT MO TA CHUNG LOAI ITRANG TF{IET BI Y TE NX{AP KHAU1. Alhunrin

STT Dd mqc N$i dung m6 tfr t6m tit1 MO te sin phim trangttriOt Uly tO

t.l M6 te hoa chdt chAn

do6n dirng cho may ;titnghiCm sinh h6e

Liirt thu chari doin i'iibumin dri':r tr,-in nguyd:r lr'Lrii,.ir'r i,.',,.,';,.khi co srrtlia. dOi n":arr sac cua::,x: chat sau khi lrir:r rr;; .;,i.,:tlianh.R I !,uccinate bufler 50.0 mmoli i,: l--romocresoliil.*-.:r c 3l11 ;:0.1-i mmol,'L: Cfc cl:6t hoat dO;rg bi rnat khilnipiii:i i;r i,ii-:iiiir.Bar; quAn. Biio qudn o nhi6t cii, 15-25 oC. xerr ngdy h*it h.rr ii*r: 1..1,, ! :

. Sau khi mo,riip. tliLr6c thir' 6n iilnl: d6n 60 rrgar i ur-r .,-r,. - -i,,,::rnip ngay vaCuoc bdc v€ khoir:l':i6rn bdn, bdc hcri. li;:i: i:iirr.r i;,.rr.

tiSp: vA du'oc liru trir ir dfrng nhiOt ci6 bao qudn.

1.2 Danh muc linh ki6n vdphs kiQn (kO c6 h6ach6t ai tem;

Khorrg

t.3 Mgc dich/Chi dinh sudung nhu ghi tr6n nh6m

Chlt thu char: tJoin do nons clo.\lhrrmin tro,lg ['r.,r,]i i,i,,, ,. i,, .,.

hu.v6t thanh.Eir:h lu'crng aibumin iit quan trons irong viQc c16.*t: giri iiir'i.'ning gan vi tiieo d6! trong thiri g.iil: b! bgnh gatr. tiri*:: ', i;:.-"

dar::-i gi5 tinh ;rang cilav m5u vli sri., dinh du0ng.

1.4 Hu6ng d6n sri'dr,rng I-{6a ch6t an i-rran Ci6 srr dungBiroc s6ng di;: ),,531i (600-670) nm. Nhi6t clO ldrrr viic:: -i?.'1 .

Piiuong ph;ip do: Diirn cu6i1\'{6u: huy6t tlianh ncic huy€t iu'i-;ng.Khiing sir dqr:g cic rnAu tan m6u.Ni:"r liiy m6u Lru6'c bfi'a 5n.Alt,unrin 6n ciinh trcxrg miu len ridn 7 ngdy o nhiit i.iii i,{-.1: -i

hoac 30 nga5, o 2-8'{1.

1.5 Ch5ng chi dinh KhLlng su'dur:g ngo;\i muc dich n<dt: nghi6m Albulni:r ti'*r';!^ il;riringr-;'o'i

1.6 Canh bdo rA thdn trorrg Se n phArn kh0ng dutic phin loqi li: san phArn ngr;v hi*i:i i;.;-,

nhien, thudc tir[t'rrin dutrc xu'11 can thdn. thec tl:irl. i-iii*:j iii,,',.;:.:tlii nghi€m t6r.Chil i,: thutic rhu'chira Sodium Azicle (0.095%) !a;-;; r:hat n;ri;

I .i , :qtx:n. lranlr r:uot ra liep xiic rr idc. mit ra rriirri tir,.r-.

1.7 T6c dung bdt ioi c6 ti:6xay ra

Kh; dO lrdt ha:: ghi tr$n vc, hQp.

'l Th6ng tin sdn plrim ilf, luu i:rnh t4i c:ic nrrti';: (n6u c6)Nu6c d6 phd du1,et ciio phdp lLru hirnh srr ;rirAr:: C0ng cld::g ,i"iung ChlLi Ar:.

3 Chi {Iinh iIfl tldng kf 6'c6c nufc kh6c (n6u c6)

I

@ihantoirn/vQnhdnhd6ngluufcfras6nptr6mtrangtni5tn1yt6I Hang sAn xuAt dpt ISO I 3485:20 I 2 vd ISO 900 I :2008

I-ldng h6a hoirn tohn i,6 hai r6; con ngu<ri.

W-trli gl,ln,frtrld-

\,,r'.i.\*tili \'?'r' \ a--tst

t:/0.i

/:*/

$C}NC TY

tmcn 11ll[u lutit4l

cOuo tlcii* YiH

& GlA0 DU

POB

nh$p khiu

ciAu ooc

m,'-9/itActl ttuttr

= I cotlo ltcl

'*\ scti.cW

cONc rY TNHHcONc NGHF v rn c cIAo DUC PeB

56: lIAJK-PQB

CQNG gOa Xe. UgI CUU Nr.;g'gi,s 1'1{'''t- 1. :'*}D6c 16e-; - Tu'do - H;ra:lt ;-,!reil

Tp Hd Noi, ngdy l-l thdn:: {}: n;i*; }{i!1

TAr LrEU KY rHUAr Mo rA CHUNG LOAI qR.ANG TE{IET BI Y TE NHAP KI{AUZ. A[,P

STT D6 muc Ndi dung m6 tfr t6m tit1 MO te sf,n ph6rn trang ttri6t biy t51.1 MO ta hSachdt

chAn do6n diingcho m6y xdtnghiQm sinh h6a

Ch6t thi.r'chAn do6n ,41-P c|,ratr6n ngu;r,0n ilf do dQ h6p thg ki:i .ii -.Lr

rhay ddi rrdu sdc cr-,a hoa cirdt sau khi tron v6'i huy6t thrai.:ii.

Alkalin.- phosphatase (Ali';i xtc t6c qu6 trinh thty phan" l:"*r:'*: ii:i.;i

iiudn g ki;1m, cua p- rr itroplieny lphosphatc thirnh p-n i trophcttt i va

irhosphr;tc. T5i 16 i5*g hdp ihu do sg hinl: thirnh cua p-riiilr;1ti:;:l:i;i i-r i,:

thuAn vi:ri hoat ddnS: AL,P rniu.I{l: Diettranolamint bufier'" pF{ 9"8 3.j nroill

riragnesium chloride l.G mmol/Lf{2: P-nitrophenylphosphaie 45.0 mm+ii i-

[]ao quun

" B6o quan cr nhiQt riQ?-8 oC. xem ngilr, hdt han trdn bi:o i;:.

" Sau kiri md ndp.ll:ufrc thir 0n dinh din 90 ngdy n€Lr dt.r'ire ril:,r'- ,,,,,'*gay va ciLioc bao r:i khoi *hi5m bAn. *dc hoi. anh sin:l ir*r iiiit r.';'r

ciuoc lu'u lrir o'd*ng nhi0t,-;6 bAo quA*.DQ 6n ciir:h cira dung dich ldm viQc (Rl - R2): 20 ngdr,., i;'l-g"i l.

1.2 Danh mqc linhki€n vd php kiQn

ftC ca h6a ch6t dikdm)

Khdng

1.3 Mpc dich/Chitllnh su dung nhughi tr€n nh6m

tlli6t thiL ':hAn doiin Jo edr:g clQ ALP.rior: mau. Tir:g:;+;is .iu.ti-i'trong cac bOnh gain irach co rhdnh phAn cholostatic. r,ang ilit" :<it, se;lr:r6t, u ga;r ngu,v€n;:h6t hoacthirph6t. ALP cungtlng i€* ito:.t'. .-;iu

benh v€ xlrong nhu o6nh Paget, b6nh coi xuo'ng vd bdnh xur*'rg !ii':+F"

irgd ddc vitamin D.

t.4 Hufng d5n sti'

dungIloa chit an toan di su'dur:g.ilu'o'c sdrrg do: i" : 4i)5 (401i- 41 0) nrn. Nili9t dQ larrt i'ii'i,: j,"'i'.llhuo'ng ph6p do: Diing hoc. DO thu5c ihu o' l5-25 'Cltriiri''.: i<i:. -,

cuIe.lu{iu: Huvtit thanh hoic henarin huy5t tudng. Kh0ng su dr-ing *itirchdng c1,3ng m6u Fhf...Kh'..ing sir dung cii* m6u tan rnari" i-;iJ,' :,ril, ,.i',.,,cfuo. c thl,Lc hi6n. t6t *hdt. sau 8 girr sau arr. ALP 6n dinir tri.,'ir,j i-irai; iinddn7ngd1,02-8''C.

1.5 Ch6ng chi dinh Khdng s*'dung ngc,rii irruc ,Jich xdt ngi:ie:l ALP rrong irti:-; r;;iii+i

1.6 Cinh b6o vd thflntrgng

Sdn.pharr; khdng dr.ic.c phiin loai ld sdr': phfirn nguy hi6rn. i i;r'i:ii,i:,r-thLr6c thir rr0n du<rc ru i1., cin thAn, tht:c ihirc hhnh pnr\l:g i!:i *gir:ii::t;5t. ClhLi r':thudc thrchira Sodiun A;:idr: (0.095%i Ian: ui-rii iri,, ',i;:i,,i'ranh nuit vdr ti€p .'.uc v6i da, mdt vir :tictn mac.

1.1 1'6c dung Udt t<;r; Khi de h6:t han ghi rr'dn vo !rOp.

l

c6 thC x|y ra,,

Th6ng tin sin phArn dfl luu hinh t4i c6c nudc (n6u c6)Nudc dd ph6 duyQt cho phdp luu hlrnh s&n phAnt: CQng d6ng chung Chdu Au.

3 Chi ilinh ttfl ttlng k;f & cr[c nr6c khr{c (niiu ca)

4 Th6ng tin vd tinh a* toirn/r,0rr hinh cl:rng laru 3r cua s6n pl':€m trang thi6't ir!r tiHing sAn xuit dat ISt) 13485:1012 vd I!,0 9()0i:2008Hdng hoa hoan toir. i o lrai r or con ngLri,,.

,r':1i,q o D6Eit-

iiry#; .4r\r-d\,H \ *''r \*tj*

CO|.IG TY

lMCii t{tiIild {fd HA|i

c0no nct+i v tH

& GIAO

PO

@(:"/cbrt.3/mlctitqtl=( coNG\cr\ &G\A(

*g)*-P(

c0Nc rY TNHHcONc Ncnp Y rE e crAo DUC PeB

56: l1ArIK_FQB

TAr LrEU xY rnu4r nn0 rA cnuNc Lo4TERANG TIIIET BI y rE ltHdr xnAu

ceNG HoA xa ugr cxt ruct*i,r vaq:'x'tr,qi"otDQ* l$p - Tu do - FI4n'$t phtat:

Tp Hd |ir)i, ngdy l1 th<iri,i i)- riir; ]iii'''

3. ALT-GPTSTT Dd mgc NQi dung md tf, t6m tit1 MO te sin phArn trang ttri6t Uiy tii

Ll MO ta h6a chAt

chAn doSn dirngcho mriy x6tnghiQm sinh h6a

q-h6tthri rhdn doan Ai-T'-CPl'ctru'atren ngulen lj 'Jo rii'irr.i, ii:rr ii:i r,r;

\..r tha) tit,i rnau sic ;ua nt:;t chat S0Lr iiiti tron rtli hulci l,t:.1:i,

f,nzymal amiirotransf'erase enzym iAt.T) (hoqc giir'r*ir.:i;-1'-i 1111 i,"'

transaminase GPT) xfc t6c phdn fng giila a-ketoglutaiiite r";i i.-airi;:ii:rciro gluiamate vir acid py'ru','ic. Khi cL-r ilrctate deiry'diuge;r*sc ii i-]ii;.:rxir pyruvic phan ii'ng vo'i NADH chc axil lactic vir N,t[]-. I' ic ;:i;i::r:,lrdp thu jlr qua trinh 6xy hoa NADH din NAD+ tpli: ti*;--' :-',, i.: '" g'i ilrr,:,ddng Ai,i'm5u.ti1 G'.:cds buffcr:rH 7.5 80.0 mmoji i

L-aianine 50C.0 mmcl/LLDi{ > 1500 iJlL

R2 Gooils buffer pll T .5 80.0 mmol,'i.u-ketoglLitaratt 65.C l:tmol/LN'\ilL{> l.lSrnmolrl

rlao qui:n

" 136o q:-i6n o nhigt o0 ?-8 oC. xem ngiy.ir3t han tr0n biio i:l.

. Sau kl:i m0 ndp, tiruOc ti:u'6n dinh d6n 90 ngiry n6ti diii:i .!i.'ilg ni;ii-lgay va cir,rcvc b6o -i6 khoi nhi0m bAn. bi)c ho'i. 6nh s*l:g iir-ii iii:i; '.1duoc luir'rrii"o'd[rng nliiQt c( bdo quar,.

D6 0n dir':li c[ra dun, dich iam viec (Ri , R2): 20 ngirf * ]-i'i'"1.2 Danh mr,rc linh

kiQn vi phu kiQn

ftc ca h6a ch6t dikdm)

(hong

1.3 Msc dfch/Chidlnh sir dung nhughi tr6n nh6m

lhdt thu'chdn da6li do no;rg dO Al,'i'-CI:''f trong mau. r'ri:lii-rr i.^:';J",rri

nir1, dic biQt phong shir trotg gan. Vi '16]'" d0 hoat d.6ng c;]l irii': i:itlir:ritrong hui,0t thanhl;; rt6r diu hi6u cue tOn thurmg te bi:c:1,;;. iii.:'i .'';,

(iPT ca.i g6p i0 iA:; gio'i i:an binh thrcng tren tronl: ti";:'i:'r:r-r i:r.;l'.1;:.i:gan vin:a hoac nhi6m Ceic c giai doar: cAp.5 dOn l0 lir: ii'l;,,. i::-'\'','-no-p vhng Ca do choiostai.ic" vi6m gan man vd xo gan.

1.4 Hu6ng d5n s&

dungl-l6a chir. :rn toin de s{rdu*g.Suri'c song do: 340 i33zi-36:.) nm. Nhict,Jd ldin vi(c: 37"{ . iriri:,;;;1,phap dc: DQng hqc. D0 trr.rdi thu' o' f -i-25 'Cl tru6c khi iL: iir.:i'!!.L,{6u: IJirl et thanh l-:o5c [ru'..,et tu'ong ci:6ng d6ng bing i]D I A. r',1:iii:s.u'Curiu cri m,iu:ar{ ;11i:r.r. ' .iv rttiu pli:ri iiu'o-c thttc hicrr" i, , ;ir:,i -r ,; :i

gio'sau 5c. ALl- giiiin sau -i ngdy (<10%) ii 2-8'C.

1.5 Ch6ng chi dlnh Khdrrg su dLrng ngolii muc ,Jich xdt nghi6rr ALT-CP1 iroris *ltii itgr.ir;i

1.6 Cinh brio vir thAn Sari pham kh6ng du'rrc phirr lopi la s6n phim nguy hi€rr"i. i'i:1,' ;tlii,3ir.

trong tiru5c thrr n€n dutvc rtu lr c.in tlian. titc,r rhuc hdnh phttti:: l-i:i ir;iiii:l:r;5t. Chrjr 1: thu5c thri chii'a Sodium Azide (0.095%) larr: chilt i'r., ,:Lir:;i.; . .;.frtinh nLrot va tidp i,tic v*i da. mit vd tri€m mac.

1.7 Tric dung UAt tqic6 th6 xiry ra

--, . -:. : .

Khi de trrit han ghi r:'in ro irttp.

1 Th6ng tin sin phim tI6 luu hirnh tpi c6c nutc (n6u c6)Nu6c?a phd duygt cho ph6p luu hdnh sdn ph6m: CQng ddng chung ChAu Au.

3 Chi ttinh iIfr iting lrf & crlc nr6c kh6c {niiu c6)

4 Th6ng tin vd tfnh an tohn/v{n hinh tl6ng luu y cfra sf,n phim trang tfri5t U! y ttiHdng s6n

"u6t dpt ISO 13485:2012 vit ISO 9001:2008

Hdng h6a hodn todn v0 hai v6'i con nguli.

.fiif-D%tol{d'N2"";4 gaug rl Nl{tucttllHtgr+liJuHAl Vs. /

"1,r," *^r\ v ri \-*\ u'::.'l:'],1;' /*'

-aN";CIt 7Wry9

TY\it'JU HAll

Ivrr

/ c6ttcrucn}{Httu

c0ilG NGi'

& GIAO

\PO

trfl-i-trfii gl,ilr,fitrid,

l

C6NG TY TNHHcONc NGHE, Y rE * crAo DUC PeB

56: 1INK_PQB

CQNG HOA XA HQI CHU NCl!tA vlFi'g H:tl'EDQc X$i; - Tr; do - Flgmk plae!e

Tp Hit N$i. ngdy 14 thdnp ti7 r*;n )it! '

TAI LIEU KY THUAT MO TA CUUXG LOAIfRANG THIET BI Y TE NIIAP KHAU4. Arn

STT DO mgc NQi dung m6 t6 t6mtiltI MO te sin phAm t rang thi6t hiy t61.1 MO t6 h6a ch6t

ch6n do6n dirngcho m6y x6tnghiQm sinh h6a

Chit thiL chAn do6n Amylase dr,r'a tr6n i;guy6n l1i dc <i6 itii: t.1:r: i,i:i ,.:ii

su thay'.l(;i mdu sic cua hria ch6t sau Lhi tt'On vo'i hu3'er ii::i*!r,'\mylase iriry" phan cic CNi'G3 thirnh glucose polyrne -r' ri-,\:] :' ;.

_ ,itring hap tiru. dc p-riitrophe-nol. la t"r-' lq thuin vcri hoat diing ii;iir. i;i=;:

:trong m3li.lll N4ES buffer ph fi.0 90.0 mrnol/L

sodiurl chloride 50G.0 rnmciilpotusrium suipl-racyanide 0.50 mcl,'[.cirlcium acetate 7.2 rnntollLCNPG3 2.7 mm'tllL

iiarr qtt;it. 86o qttait o'nhiQt d+ ?-8 'C, xem ngliS,.hit han tr6n br.ci bi. Sau ki:i mo nip, thudc th[L 6n dinh r{6n 60 ngiry n€r: dri{.}r: i{}i-rg ir;::rirga\ \a ritLtvc batl 'i'khoi nhidm ba;r. h.rc hoi. dntr::it:! i;;,1, i-',t \;iduoc lulr:rfi'o'dirng nhigt ci$ b6o qudri^

1.2 Danh muc linhkiQn vd phs kiQn

ft€ ca h6a ch6t dikdm)

:'.hdng

t.3 Muc dfch/Chidlnh sri dgng nhughi tr6n nh6m

(lh6t thr:'chAn tJoan rlo nr)ng d6 Am1'lase trong m6u. '[a*g, ar:rr i;::r, ; ., :IrLr..ct Ihlr,lr lhrry€t r.ionr]: tron{.chin,loair iiem 1r:5 r:;,,t. 1:;i'i..'r:iOu: Sc, s;inh am1'lese trong huyCttl:a:':h. rii nuoc ti0u cri lhe gir;l ':i:l:;idodn phin bi€t c6c ti'urrng i-rcrp.t[ng htii€; ap thu'c su'r'ci ai:11.i;ii.: ,rii;cac, sll)'thAn. am5rlase niQu thAp vd rlsCrLaslrt.v'lasemia v<.ii :l-rt'. ir, ''

rrucrc ti€u binh thud'i^rg.

1.4 Hudng ddn stidung

j'l6a ch6t an torin d6 sfi' elung.

Iiut'rc s6ni4 do: )": .11]5 (400-440) nm. ]rhiOi dQ ldm vi6c: 17"i,. i,:r::",.ii:r!.

ph6p dc: il6ng hoc. D€ thLr0c th'# o' 1-.{-25 oC tru'6c khi sti.lt.r;i..-.

h{iu: H,-i1,',,1t thanh hoiic hu., 6t tu'ong ci:0ilg ciong bani: ll i} t," i. ,'ir,;111;

:u'Jurig c-,c miu lar, rnau. i iv mAu ph.ii riuoc thu'c hi[r',- t,,i ,r::,li. :;i": ]i

gid sau zin" AI-T giriin sau 3 ngdy (<l C%i o 2-8"C.

1.5 Ch6ng chi dinh Kh0ng sil dung ngoai muc dich xit nglii6m Amylase trc*g i:;i:ii ::::i:ili

1.6 C6nh b5o vi th{ntrong

san.phdm kh6ng dutrc phA:: loai lh san ph;lm nguy hidrn. 'i'iro r:iri.1;.i.

tiruiic thu' i:0n ducc rrrr 11,' cin thdn, thco thuc hirnh phdng iiii j'lliii;rlr^ri

l.rjt. Chri.i thutic.thilchi'a {oclium AziJe (0.095%) lint cj:.-r; i,'.^r. -,r.,;r;,'irf;nh nilGt r,'d riOp ruc r,,ti'i Ja, r:'l6t vd ri6nr nrac.

1.7 T6c dsng f6t tqic6 th€ xhy ru

i<.hi dC l.r6t han ghl ti0n vo i;6p.

2 Thdng tin sin phim di luu hdrnh tgi cic nucrc (ni!u c6)Nudc?a ph6 duyQt cho ph6p luu hdn-h s6n phAm: CQng d6ng chsng Chdu Au"

3 Chi tlinh iIfl fl6ng ir$'& cic nufc khr{c (niiu c6)

4 Th6ng tin vd tinh an tohn/vfn hdrnh tl6ng luu f cria sfln ph6m trang thiiit niy ti5

Hdng sin xu6t d4t ISO 13485:2012vit ISO 9081:2008Hing h6a hoin todn v0 hai vdi con ngudi.

h$p khf;u

o\N \'+'i\.'i*

Kfi';/lRAil"t I cot{

wZc6r'icIRACitl'l|iNl

cof{G NGI

&GIAO\po

,flWtrttfllWffi;o

*-K*

re76,-1/RAcHNhr'

=[ gsNGN"

,*\ &GlAr\#

l

c0Nc rY TNHHcOwc NGHE v rn c. cIAo DUC PeB

56: l IAJK_PQB T1: IIit Ltt)i, ngdv ll thdng {i7 ni"m .:Li! ,-

THIET BI Y TE NHAP KHAU

CQNG I{OA Xi HQI CHii NGH?i*" 1"'*s.'[ \ 1 xlDQc l$p - Tg do - Fiirerh pE:ue

0r- r -'\---:.:{}.G !'i 'r;:rr1

:lil iiW HAN \'*:m 5uu nhil \'r-^, \;

sHEYTE li0DUC l-rE /E/:<y

5. AST-GOTSTT DO mgc NQi dung rnO ti t6m titI MO ti sfrn phirn trang ttri6t Ui y t6

1.1 MO te h6a chAt

chAn dorln dirngcho m5y xdtnghiQm sinh h6a

Clh6t thii ch6n doan AST-GOT du'a treLi r:guycn Iy .1o .i.-, !:.in ii;r-r iihi r:r;

su thay dOi mdu sic cria hda ch6t sau i<hitr6n v6i hui,6t tii:;i;h.il6c mel aspartate-a;niriotransferase (ASTi {hoac gitrtaiilir:-i,,r.-;ir,.;.'.ri.iransamii'rase GOT1:<0c r6c phan flng giila u-ketogir-rtar"*ir.i;i i -

ispartate ciro glutan:ate vir craloacetal"e . Tr:ong su'cd ntil i:.1:iiehydrog*rase malate (M[ltl), oxaioaeeiate phan rl'ng irit'i h../ri,1ii iriri'i11aiate ..,ir NAD +. T !, lQ giam h6p thu .Jo iiu6 trinh oxy hi_:a \, ii ji I rir, :

:\AD + trac ti€p ty ii voi hoai clOng c'ie iriiu z\Sl'.R I Goods buffer pFi 7.8 8i1.0 mmol/l

l--a5pertate 2-1C.0 nttnr:liLLD;r -r8C0L

\,lLlU > 800 Uii-tl2 Goocis bur'fbr pf1 7.fi 80.0 mmol/i.

o-kei.ogluiarate 65.0 nimol/LNADH > l.l8 rr':mol/I ,

lido quan. 86o q;,:it;r o nhiQt rirr 2-B oC. xenr ng;:'t.hit han tr6n bnri bi., Sau kl:i n'ro nhp.lrrLroc tl:[i dn dinh,i€i':90 ngdl'n€i:.iriiri: iir;:,: '=;:':

ngay va cir-Lo'c bao ie khoj ;rhi6m bAn. bOc hoi. 6rrlr sdr:'* ::'ic li;r,:','uduryc luu tr['cr d[rng nhi6t CO b6o quin.DQ dn Cini: cua dung dich ia'm vi6c (RI - R2): 20 nga,r, o 2-l:'i'

1.2 Danh muc linlrkiQn vd phu kign(kC ca h6a chit dikdm)

(h0ng

1.3 Mpc dfch/Chitllnh sri dpng nhughi tr6n nh6m

{lh6t thrr r:hAn doan do n0ng d6 AST-ajGi'trong m6u. Nhiir-::i t'ir:r,'!;r-:nd1, dic bi,6t phong phir tro;ig gan. Vi r,?)', C0 hoqt .lQng cac iue. ciii,:ri{irong hr"iyit thanh ld mOt diri hi6u cua tOn thuo-ng t0 hArl *ar:. i. ii ii' -,.:r

i-;FT cat-r gip l0lAn gi6i hrrn binh thur,.'ng tr6n trong truc*u l-ri.,i; ''ii:r:iran virLri iro5c nhi6r:r dQc L!giai doan c5p.5 d6n 101,1n iiriri;. i;"rii;:ri.:i;irp vdng rja do chciostalic" vi6m gan nran vd xo gan.

1.4 Huong d5n sirdung

l{6a chi.t :i:r toan dC su'di.rng.Elu'6c sc,ng do: 340 i-:34-365) nm. Nhi*t Cd ldm vi€c: -17"1'. ili.i'r;,rr.ij

uhiip dc: i)6ng hoc. OO tnuSc thii o i-5-25 "C tru6c khi su rliin;.\46u: F{uy0t thanh l:odc hu;,6t tuong ci.:6;rg dOng bnng i-I}'1,}r. (-i:iiriu:iu'dun-rr cic miu tar mdiu. i,i,v mAu phai cu'oc thpc hieir" i.it r,irit. r;ri; lii:ic sau ;:n. ALI giarn sau i ngdy (<itl%t ri 2-8'C.

1.5 Chdng chi dinh (hdng ru'ilung ngo;,ii rnuc rlich xdt nglriir:: AS'|-CG i' 1i'ri:rr ii-:;:ii:lgu'tli

1.6 C6nh b6o vd th4ntrgng

Sdn.phdm i<h6ng du'.rc ph€.n loai ld s6n phlnr ngu5, hi6rn. 'ili;,, rrirr,:r.i,

ihudc thir n6n clucic tir lj'cirr thAn, theo thuc hdnh pl'iorrg riii ngi.:ir:;:tdt" Cnf y: thu5c thu'chu'a Sodium Azide i0.095%) lan: ch*i b.rti irriir;r

i . ,:flrinh nui,t vd tiep :.irc v5'i da, m5t vd r:ieri-: mac.

1.7 Trlc dyng UAt tqi,,1.

co tne xay raKhi de h6i han ghitren vo,i.:6p.

) Thdng tin sin ph6m iIfl luu hinh t4i c6c nufc (ntiu c6)Nu6c dd phd duyQt cho ph6p luu hdnh sin phAm: CQng d6ng chung ChAu Au.

3 Chi ilinh tt6 tl5ng ky & cric nufc khr[c (n6u c6)

4 Th6ng tin r'6 tinia ac t,"ran/.".*sl hixrh d*ng ltrur y ciia siin ph6m trang thi#-i hi E tS

Hdng s6n xudt dat lSi) 13485:1012 vd ISO 900 i:2008Hdng h6a hodir toan r,0 hAi voi con ngui;i.

;/if::::t- ;;''// '<\'/ r';h.tri WiV Lha/"s/TRi;rrffiil ri,',ifuilE I couc Ncbi\i Y TE

w.**;t*2*

K-. 1

JIAM

,{.qL

(u%*-!/1xlcttNf'=[ coNc\,t\ &Glt

\*

,/W-trligflild,t#trfri*

cONc rY TNIrHcoNc Ncnp, v rs a ctAo DUC PeB

56: lIAIK-PQB

csNG HOA X,,i Uqtr CriU Xr-;rSE,q VEF f I -"':E$c i&p - Tu do - Nilaeh ;:Et{rc

Tp Hd |iQi, ngdy l,l rltrin,: {)7 ri:i; }{ii .

TAr LrE-'.U KY THU4T MO rA CHUNG LOAI {RANG TI{IET BI Y TE NHAP KE{AU6. Calcium ASX

STT Dii muc NQi dung md tf, t6m titI MA tA sin ph6rn trang ttriGt Ui y t6

1.1 MO ta h6a ch6tchAn do6n dirngcho m6y xdtnghiQm sinh h6a

ChAt thu'chAn doSn Calcium ASX dua tr6n nguy6n i{ ifo riii irril: ii:i;khi c6 su'thay d6i r:rdu sir, cira h6a chit sau khi tron r,+i iiii-t=i li:ir:tl:.Arsenazo ill. voi stL hi€rn clidn cua iun canxi trong rn6i ;"ruiriig pi:i

irung hi;a. tao ra ;n"it phuc hop miru cc ci:rrng d6 miiu ,Lriri^l1r r-l't:c. v.!in6ng do eanxi trcnl: ;rr6u tiru' nghidm.,rd I Gocds bufi'er pl : 6.8 1(;[i.0 mmolrl

Arse nazo III 0..i,3 rnmol,LCalibrator Concr:ntratic;n cn 'u'ial laSe I

ilao quan

" Bao quain d'nhiQt d0.15-25 oC. xetn r:ga-..'hdt han tr0i:'bat hi.

" -sau khi mo'ndp, tliu6c thri 6n dinh ciin 9C ngdv n0u dtroc r'ir;tig ;-lIir

ngay va duoc bdc vr khtii irhi6rn bAn. irdc hrri. 5nh sfnu. antc ti'i;: vli

riuo'c luu iifi'o'dung lrhi0t ii6 bao qu6r.

1.2 Danh muc [!nhki6n vd phu kiqn(k0 ca hoa ch6t dikdm)

Kh6ng

1.3 Muc dich/Chidinh srlr duir-s nhlighi trdn nhonr

{lh6t thL: ,:han doiirr Jo rdi-,g clQ Calcii"r:n lrong m6u. '['r-*t:{ i:r.;.' ',iiranlr. L-aiiiunr co i-a ilang: ,i5o% proto-in liSn k6t vd'i pi'*i*r:.; i.lr; .!'liia alburni:r). 8t% tro:ig phiic ho-p v6i pl-iosphate, sLrlf-ate rrii ciu'.:rti:. '.;1

45% d4ng tu do.ior: hoa thi hoat d6ng. Calcium duoc iliem si-,*t ch;iichd dC dul'tri n6ng dd canxi tu do trong huy€t thanh d0 ,iai:; i;;ilr di,.'r':.; . ,{,,th€ mdng te bdo cue cac mo dC bi kfch thfch cfrng nhu'i:ir: ii.;:r-,ns

canxi xlrorrg.

1.4 Hu6ng d6n sirdung

il6a ch;it an todn di su',rjur;g.

Ilu6c si:ng do: ), : 6,i0 (60G-570) nm. trhi+t dQ ldm viec: l',r-{'. r::.ri i:':ph6p do: DQng hqc. D0 thirdc thu o 1"5-25oC tru6'c kiri sii ii*riglvldu: Hu;''0t thanh hcdc heparin huy€t tucng. Kh0ng su'cui:rr i:i'eichSng d0;rg miu kl-rac..Khong sf dung cic m6u tan n:iru. i.ii', rrrir, i.i::,iduo-c thirc hi€n, tot nhdtr., sau 8 gid'sau dn. Calcium 0n d!irir ii'ciig :itii:,i; ngal rr l-8o('vi S lhdrrg o -200C.

1.5 Ch6ng chi dinh tiir6ng sir dung ngt;ai muc dich xdt nghifrri Calcium ASl' l:li:; :,i...r

irgu'di

1.6 Cinh b6o vd th4ntrgng

San.ph6,rr khdng diiirc ph6;r loai lh sdr: phim nguy hi€m" 1':;r' i:iiiilt'i.thu6c thu'nOn duoc xfi 1-1, cin thAn. thto rl':uc hdnh phc;-'i: li r ;-'Eiii.ir;:

tilt.Chir 1i: tiiu6c tnu'chu'a Sc<j!um Azide (C.095%) ldni ci.ijlt **i: iiri.i,,.'fr6nh ruiia vd ti6p :.irc vtil da, rndt vd :ridm mac.

1.7 T6c dpng Udt tqic6 th6 xtry ra

Khi dC ir0t han ghitr6n vo hOp.

) Th6ng tin sfrn phAm di luu hdrnh t4i crtc nu6'i (n6u c6)Nu6c tt6 ph6 duyQt cho ph6p luu hdnh san phAm: CQng c16ng chung ChAu Au"

3 Chi illnh ilfl ii6mg k;i & cric n*6c khr{c (n6u cb)

4 Th6ng tin v6 tinh an toin/v$n hdrnh tl6ng luu y cfra sin ph6m trang ttri6t Ui y tliHdng sdn xuAt dat ISO 13485:2012vit ISO 9001:2008Hdng h6a hodn toirn v0 hai v6'i con ngud'i.

{^xqi1}6t.'/S^'Yz--r,\/ niun rY

wCONG TY

rmcn l{nliu l'rll.ttt4H

cduc HcH( \i(

clAna ooc

ry-fr.trl,i ?h,turfrtrii,

ffi-9/ttlctttl'=( conor,*\ &Guw

c0Nc rY TNtr{HcONc mcuF Y TE c. crAo DUC PeB

56: 11ArIK_PQB Tp Hd l{6i, r:gdy l1 th-lng iit i:i'ir: 2{}i"

TAI LIEU KY THUAT MO TA CHUNG LOAI{RANG TE{IET BI Y TE NHAP KHAU

cqNG HOA XA HQI CHU rucriE,L vil.: 5 l\lDQc iap - Tg'do - Fl+nli tr-:tu1!1

7. Calcium OCP

STT D6 muc NQi dung md ti tdm tit1 Md te sfrn phirn trang ttritit fiy tG

1.1 MO ti h6ach6,tchAn dorin dtrngcho mrly xdtnghi0m sinh h6a

Ch6t thLL ch6n ,Jo6.n Calcium OCF du'zi ire:n nguy6n lv dc ri,.i i;;rrr ir,,; r.r:ico su thar,- d6i mdu sic cia h6a oh6t sair itlri tron r,'oi hLrr il iii::,rn. 1]i;ir,i

iti6u kiQn iua alcalir'e, O-ci-eso"lphtalein cornplexone (GP['] pi-rii* un,:.

vo'i ion c-anxi vd maunesium d0 tao tha;rh mOt ph6'c ho-p tiri'r: ;1*:ir

iiucrng clia magnesiirnr lri iic ch5 boi sir l:iqn di0n 8-hycire;:.1quliii;ii;:.t'6c Lri6r: phfp hAp ihu ducrc thu'c hi€n ,-r 570 nm. Su t6lrg ilrip ti;r.i **r;hri'c hcp iim ti 16 ti:uAn vGi n6ng d6 can:<i trong miu thii ;:gi:iii::.:il AMi'}bLrlfer pH lG.-l :1'1.0 mmoi/1.I{2 O-cresolphtaleir: compiexone 0. I tr inmol/L

8-h,vdloxyquinol ine 9.0 mmol/l-86o quan

" Bio quan onhi6t iJ$ l5-25'C, rem n;'d1, hdt han tr€.n b;lc hi.:,. Sau klii tno ndp, thudc th[L 6n dinh J€n 90 ngay'ri€u cil-iiir-: "irir.:g

i:iii;itgay vd ciu'o-c biro r'6 kl,oi nhi6m bA;r. t'',ic iroi. i;rli :.irr: l.'.r'c:,riip ,:rr,iu'irc lu,-r irir d dfrng rhiet d+ bao quiin.Ni6 6n dir:ir cira dung dich lim vi6c (Ri + R2): I ngdf ir i5-:-:,"('.

1.2 Danh muc linhki6n vi phs kiQn

ftC ca h6a ch6t dikdm)

iih0ng

1.3 Msc dich/Chidinh s0'dung nhughi tr6n nh6m

, h.ii tlrr, , han Join ..1.r rrt\riJ clo Ca!cir,,n ti()irg rnaLr .'. l:11, ,i:1: ;1r',.doirn do niin-t cl6 Csicium trong m6u. 'i-rcng huydt:har:ir. ,-alciLii;: er.,

ba dang: +570 protei;t lien k6t voi protein rchu .v6u la aibuir:ir:). E,tt;:oi,g phiic hcrp viri i:hosphate. sulfbte '"zd citrate. r,'a 4-59r dang tu.dt; i,rnir6a th6 hr-.at dong. i-alcium duoc ki6ni so6t chdt chE d0 ciiry r:-i r:i,;iu.i,icanxi tu dc trong hLiv6t tira:rh d6 darn bao diQn th€ mdn;l i3 i:r;n cr-i:i i:1;*

rn6 d5 bi iiich thich cirng nlitr ham lu'ong canxi xuong.

1.4 Huons d6n sLl'

dunsi loa chlit arr toan dC su' dung.iiuric s6ng do: )" : 5;r0 (550-590) nm. l\,hiet dd ldm vi0r:: :7''i. t'li:,;."nj-phap do: ilQng hgc. D6 thuSc thir cr i5-2-5 "C tru6'c khi sr.i ,iur:s.i\4iu: t{uy€t thanl': hoac tru',6t tuorrg. i.-hOng su' dung ciriil ci:il,lt ii,'ir,.+

m6u khirc. Khdng sLL dung elic m5u tan mr.u. L6y m5u phai iii*-r"i:1,iri.i'r-r

hi€n. tdr nh6[, sau 8 gio sai: in. Calciur.:i oil dinh trons ,::.it: ;il: iirll'i 7

ngay o l5-25 'C l'Dr .18 nga:, 6'2-8'C.

1.5 Ch6ng chi dinh ii-h6ng su'dung ngor.ii muc dich xdt rrgl.riem Calcium tri;ng rr"iil', :,-i (,;

t.6 Cinh brlo vd thdntrgng

tan.ph6rn khOng ilurrc phdr.; lo4i ld sdn phim nguy hi6r'n. iii', ;:iri,:1"tiru6c tl':u' ri6n duac xil li can thAn" theo thrrc hanh pflfi:.rg ii:i :;':i;:cr:t6t.t hu j;tlti;ric thu ch.ia SoC,urn Azidc,lt.r)')570) lirin cl;,,r ir:: ,, u:,

,I

W-trl,igl,tuftrldr

T'rirnh nutrt vd ti€p ;..ric vrii J;r. mat. ar ;,ie n.i rrac.

1.7 T6c dung U6t tqi,,4

co tne xav rat{hi dO h6t han ghi ti€n vo ir6p.

1 Th6ng tin sin phim tIfl luu trlrnh t4i c6c nufc (niiu c6)Nu6c dd ph€ duyQt cho ph6p luu hhnh s6n phAgr: CQng d6ng chung ChAu Au.

3 Chi ilinh iIfl il5ng lcf O c{c nufc kh6c (niiu c6)

4 Th6ng tin vd tinh *vr tn:\n/..,$:n hhnh dxmg lrr* y cua sdn irhi'am trang thi6t i:i r tr:

Hdng sdn xuAt dat ISO I 3485:201 2 vA I50 900 I :2008Hhng h6a hoirn toan r,6 hai r,,ri'! con nguiri.

#Pc6r'lo rY

mrcu utitfln l$ r1r

cONo lroriqf ta'

h6p kh6u

K"Ys'/' .+Zco-lftuctNt= [ s[]tc \

i\ &G\'

,I

cONc rY TNHIrcONc NcHT v ru e. crAo DUC PeB

56: 11A{K PQB

cexc itoA xA nqr cuu Nc;r-i,q !'rui i ),-i1lDQc lap - I'u do - H4nh lrinir'

T|t I{d }{Qi, ngi',, l.l thdng {i'i ;;it;; )i;it'

TAI LIEU KY THUAT MO TA CHUNG I-OAIqRANG THIET BI Y TE NHAP KI{AU8. Chloride

STT DG mgc NQi dung md t6 t6m titI MO te sin phArn trang thiiit Ui y t6

1.1 MO te h6a chStch6n do6n dr)ngcho m6y x6tnghiQm sinh h6a

Chdtthu chAn dr:5n Chlori.le dr:atrdn nguy€n 11, do clq i:ap i.i:r: i': ;,,,sLr thay C<\i rnau s[c cirir hda chAt sau lthi ;r'on voi ittrvci:i:r:ri:. i]'i:iil';::!ph6p xac dinh cloriiie cua ir€n sLj'tao ahann cUa mQt.hgp ii:ii i;.:;r;

gifr'a sat- Iii vd c6c irrn thioc5,'anat duo-c giai ph6ng bing pirili: irr;r.: r'Lu

clorua.'ci thiocl,an*t mercrage. Curir:;g iL] mdu k6t qua L;i' i3 tiir:"i;-: .',c;i

nong dri cioride trorg nrdu.i{l Me:'cLriious thiocyanate i.0 mmoli i

iron nitrate l2.ii nrnol/i.nitiic acid 7[i.C mrrrcl; i

nitraie rlercLtriiius 0.20 mmo[/Lllao quin. Rdo qu:in o'nhiQt dt2 15-25 oC, xem i:gi1'h6t han t;'€n b::c hi.

.!" Sau khi rno rrip. l:,uoc tl:u on dinh d*n.i0 ngay n6:.r .lLi'.i'' -i.'ll,: r,:,,

ngay v;r ciu'c-vc bao i'i khoi nhiSm bAn. birc ho'i, 6nh sdng iruL,-, ii.li: r iiilu'ryc ll:'u trii c drin3 nhiOt Jd bio qr-iirr;.

1.2 Danh muc lini:kiQn vd phq kiqn(kO cA h6a chdt <Ii

kdm)

Kti6ng

1.3 Muc dich/Chidlnh sir dung nhughi tr6n nh6m

Chdt thu'chdn do6r.r cfo nor:g d6 Clhioride irong m6u. Tr*ng sri cir:aing diir: tich + va - tronrl huy'6t trro*g. al- ld anion vi:ci tl'i.ri" tirrL:i

..)..ria vrc viic diOu clrinh'hr'ifch ra do ;hirn thdu cua cl;ii, ii,,r..;,.,, r:i:-.cao.

1.4 Hu6ng d6n sridung

iJ6a chit an tohn dd sir du::g.Bu'oc sorrg do: )" : 1ll0 (46()-500) nm. Nh;et d0 lam ',.,i0c: .l,i'{--Phuon-r ph6p do: D0ng hcc. EC thudc thii o' I 5-25 "{ truti'c iiiri :.Lr'

dung.MAr-r: Iiir',,€t thanh hoEc hL:1,'5t tuong. lihGng s[r dung chiii *hiiii: iii::i,::ndu khac. Khing sLL clLrrg c6c rniu tair r:r.itr. Ldy mii, pli;i iii:,.,,: :i;ri,.hien, tdt nhdt. sau I gid'saLr an. Chloride dn dinh trong n:iu i,:ri "l.r,r Ingdy o l5-25 'C vi 28 r:gay d 2-8'C.

1.5 Chdng chi dinh Khdng su dung ngcii muc dich xdt nghid:r Chloride irons ::-r;:r l_;ii,';

1.6 C6nh b5o vir thAn

trongSdn.phanr khdng dLicrc phan toai ld s6n phAm ngul, hie;:r. 'f r;:' i;i:iiii.ihuOc thti'n6n duoc xu'ly cdn thdn" theo thu'c hdnh phiiny. ihi i;piriirr:rAt

Chir 1f : thu6c thu'cl:*'a Soiiurn Azide {0.G95%) lan-r cl,6t l}ii: *riiiri.,i . .i.

lranh nuot va tiep :'[rc vd'i da, mdt vd fli3cn mac.

1.7 T6c dsng U6t tqi Khi de hOt han ghi tr0n vo hQp.

l

Wtrligl,nhy%/,k

c6 th6 x6v ra

2 Thdng tin sin ph6m dfl luu hirnh t4i c6c nufe (n6u c6)Nu6c dd ph6 duyQt cho ph6p luu hdnh s6n phAni: CQng d6ng chung ChAu Au.

3 Chi ilinh tI6 ilf,ng ky O c6c nufc kh6c (n6u c6)

4 Thdng tin vd: finh an tohn/vfn hdrnh iLing lut f cira sf,n ph6m trang thiiit bi y tCHdng sdn xu6t d4t ISO 13485:2A12vit ISO 9001:2008Hing h6a hoin tolrn vd h4i vdi con ngudi.

ffifittotshQp khffu

'#u

6%tN(,\''Ymlm tlutit* Ht]t.t HAll \.+'x{ cone uonirtE )i

Rxssqlp

m,-9/1qi\cHNHj I cotto t...

,*\ &G\F.

\#.

cONc rY TNHHcONc NGHE Y rE c crAo DUC PeB

56: lIA{K_PQB Tp Hd ltrcti, ngity l l thclng 0 ,' :tiitt ij i "'

TAI LIFU KY rHUAT M0 rA cHUNG Lo4rrrRANG rHrET BI y rE NUAF Kr{Au

CQNG nOa XA F{QI CHLr nCr*En !.iii'} ;" {.olDQc xAp - Tr,r do - Flamia ;;Eruc

9. Chcles€erotr

STT EG muc NQi dung m6 tfr t6m titI MO te sin phim trang ttri5t ni y tii1.1 MO ta h6a ch6t

chAn clo6n dingcho m6y xdtnghiCm sinh h6a

C:hftthtichAn dodn {-lholes;erol du'atr0n nguydn ly do iir, tli,c ii'rir khic,5 su thay'ddi mdu sic cilra h6a ch6t sau i<iritr6n r,6'i hLr5'ei:!:a;;h.i-lholestcroi vd Cholesterol lu'do gi6i pircng khoi este ciri: irri ::,ii;ritzyme',iiuy ph6rr curi-c o.'l;;d ho6 (CFia). Choiesterci iltlir.: ,i.'.i ':i,.:

tro'i oxyiiase cholest':rol (CilOD) thinlr ci;lest-4-en:3-ans ;,-;;i,-. . 1,:

lTycirogen peroxide. fhuoc nhudm quir:creimine duo-c tao i!::i;r,: ri:'irydrogen teroxycie irons si.J'co rndt cti:i frcioxydase (PCDi. I,-i:.r r l,r:-'vdi ztraminophenazcr:e va phenol d0 ta.-. thlinh m6t hc.'p i:lii,t rii;.:,.Cu<ing iJo mdu tuong ri'ng voi ndng dQ choiesterol trong ::-:ii; iiri:nghi6m.k I Gooils buffbr pt-i 6.8 l(-r0.0 rnmoi/i.

choiesterol ester:ise > 500 U/Lcholcsierol oxyoase >, 800 U/Lphencl 20.0 mmol/LperoxSdase > 2500 U/I.4-an, iirlphenazcile .6 n:rnol/L.

ii6o quair

" Bacl que;r o'niri€t,l:,12-8 ol. xem nga-'i ir,5t han tr€n bix; .1-,i.

.:" Sru ki,i ;no nip. t,:"roc:hu in dinh di,t O{} ngar nr\Ll duo. *ir:: ii,- ;r:riitqayvirdlroc L,ao ri khoi r:hi6m bAn, b6c hoi. anh siingtnrc ti,-:r;'..rrju'o-c luu irir o'd[rng r-rhiit dQ bdo quarr.

1.2 Danh muc iinhki6n vi phu kiQrr

(k€ ci h6a ch*t dikdm)

Kh6ng

1.3 Muc dfch/Chidlnh sri dpng nhughitr6n nh6m

{- h5t thLr chAn do6n do n6ng dd Cholesierol trong m6u. Li;*irsi,;i,;i iir, 'ltltanh phdn quan trong cua n:dng td bdii va iipoprotein^ l-;i;.rr:

eholestercil m6u. r'd Circ bift li6n quan ci€n suthila t-Dl.-ci:i.:ic:riii"i,i....;{)ie u na1 rrrong qrran d6ng k0 voi su ph6i tri0n ciut chfrlrg.r,.v r,i:',; ii,;i'r::r:rach. hiu qua cua;-iri, bQnh dQng mach vanh vd rOi loar, h,.i',;.i :,:!:i,i ,.,.

huy,'€t kli6i td.c nghEi:.

1.4 Hudng d5n sudung

ti6a chdt an toin d6 su'dung.iluS'c scng do: )" : 5 i0 (50G- 550) nm. l.Jhiet d6 ldm i,i0c: :l--l'-t'ilhuong ph6p do: Phin tich di6rn. Miu: t-l:ryift thanir ht',*c irii1,,ri i,jr,r,::., ,: ,

i'-h0ng su dung chat chOng ddng rn6u khlrc. KhOng su'ciuni: cei: ;r:*utirn m6u" I iy m5u pi;ai durrc thu'c hi0n. tot nh6t, sau I g.iir s;:i.; ,iir.

,;.r-'htrlestr-e:'ol dn dinl' i.rong,n6u i€n r"t€n 7 ngdy o' l5-25''C ',';,i.li{;:i.r"1... ,t:i-8"c.

1.5 Ch6ng chi dlnh l'.h$ng su'dung ngoi:i mLrc dfch xdt nghi6m Cholesterol tr{lii}i rielr

hAG TY \']\iNnrlurier\Li\tH6vm )[]!0DUC l:'l!lw /&!4+Y//;6/

ngu'd'i

1.6 Cdnh b6o vi thiritrong

S6n.phAm kh6ng,Ju',rc phdn toai ld sin phAm nguy hi0m. J'Lir irlriiiri.tirudc thr-r n€n cluac xu'ly cin thAn" theo thLrc hdnh phir;-i3 Li.:i l",qhiri,it0r.i-hfi i: ii:r;dc thil ch,,:'a Soclium Azide i0.095%) ldm ch*t i-1ai:!,ii;.ti,.; . .:'Ir6nh nLict va tiep xiic v6i da. rndt vd ni6r:r mac.

1.7 T6c dqng U6t tqic6 th6 xiy ra

iihi d6 hdr han ghi rL3n vo i:6p.

1 Thdng tin sf,n phAm rIfl luu hirnh t4i c{c nu0c (n6u c6)Nudc dd ph6 duyQt cho ph6p luu hdnh s6n ph6m: CQn! ddng chung ChAu Au.

3 Chi ilinh tti tting [qi & cic nu0c khrtc (n6u cd)

4 Th6ng tin v6 tinh an tohnir'$n hhnh dirng luu y cria siin ph6m trang thi€t hi q l*Hdng sAn xuAt dat IS0 13485:2012 vh lr.0 900 i :2008Hdng h6a hoin toar. vd hai vo'i con ngui;,i.

Jtl.iatiaj*i\t\

4gqry<)*,/ coNcp{orn\/RscutiNEttii',Ju

HIlt

I c0ut rcui1v tr\ aerAo o[tc

s#%t*

frp Kllau

ryWffifigl,,r,t,fitridr(-jftYcat-1/mi\cHNYj I couo tl*\ &cln.

W,X P

c0Nc rY TNTIIIcoNc NGHF y m c. crAo DUC PQB

56: 114{K PQB Tp Hdltrii, ngdy ll rhdng iil iiiti:t -)i-ri7

TAI LI{U KY THUAT MO TA CHUNG E,OAIfRANG THIET BI Y TE NHAP KHAU

cgNG HoA. xA HeI cHu rurF*EE v'r[. ] r=.-r1I

DQc E$p - Tu do - Hg*h 6;la;.ic

i I 0oal\\.r

;"t{9

N.G IY V\HIEI,I HUU |1AII \ 4NGHEYTE ) ii*AODUC I*,aB:/*v

TO" CK NACNQi dung md t6 t6m tit

MO te sin ph6rn trang ttriGt Uiy tG

MO ta h6a chdtchAn do6n dirngcho m6y xdtnghiCm sinh h6a

ilhit thrL chdn dod.n CK NAC dtra tr€n n*uy0n lli do d$ iiip:i:L: i.;li eii:t)utnav *Gr mau sac cua;rdachdt sari i<hiti6n vdi huvet illa;ii':. {,-'r'.:rrrirlr.:

iiinase >:irc tiic phan u'ng gi*'a creatine phosphate ve i\ilP. i::ri ri'i::riii,-'

",d AJ'P. ( ii6t nd.v. r'5'i srL hien di6n cua glucose vd trexr:kinrise riri{)i-lbi6n cidi tiiinh ADP r,a glui:ose 6phosirhi:t;, vri'i inlr i:u'..;l:s ,r'i:1,,

*lucose-5-1;hosphat-;-dehvliidrogenasr:. hirrh thdnh gluccs,ir-{r-;}ilr-rsi.}iii,-

gluconaie trong khi r'.iADP + giam xuong NADPI-I. [{oat ili::;* ,- iitrong miu du'crc tinh to6n iic bi€n thO hip tiru. do chuyi:.r c'iii \,,r,iil] i

ihirnh NADPH.Rl Imiciazole buft-er plJ 6.-i 150.0 mn;ol,'I

AMP ?5.0 mmol.lLNA[:P 2.0 mrroiil.D-gl :-rcr'se 25.0 rirrnclil-diadcnosine phosohate I 2.0 mmolil-herokinase 300G t-lit,magnesium acetale 12.0 nrmol/l-N-acet-;l-cistei ne 25.0 r"nmol/L

i12 Imicl:r.ur;le bufl'ei' pH ,5.-: 150.0 rnmolr[-.\l)F l-'.() 11111 ll ;,

G6P-iiH tLj000 iit.creaiine phosphate 3.5.0 rnmol/L

R6o quan

'Bao q*iirt o'nhiet ri,i 2-8oC. xem ngd-r liet han trit irao lri.

" Sau kl:i m6'nip. tirudc tl:ii 6n dinh ri€n 90 nghy n6u dr!(.-!. ilirr,r' ir ii:r'rgay va ciuo-c bAo',e khoi nhi6m bArr. t',ric hoi, Snh sri*! ti'Lr.',,i1,\.,aiutrc luu :ril rr d[rng nhift *$ bdo quir:.ilO on dini': cta dung dich iiim vi6c (R I - It2): 20 ngirl' ,;.:l-f;"(l.

Danh muc linhkiQn vd php kiQn

ft6 ca h6a chAt dikdm)

Mr,rc dich/Chidinh sri dung nhughi tr6n nh6m

i-'hdt thr-r' ,:h6n dol;-n ,Jo ni\ng dO CK Nr:,C r-iong mdLr. Vi*' i;ru: .'iir:i',:r'rng ho:.tl .:0 CK.'c -' ngriiiehdn dorirr ion o h[nh 11[;ii: ,1x.,, iii,:t: i';rtin':, vivi cac giii tri c:ro b6t thuong dr,rqrc gt,i nhan tu'i Jrirr +li *i,; -.,tiu

khi bat dAu daur ngue.

Hudng d6n sridung

i i6a chdi an torin dC sil dur:g"

lluric sc;nq do: l" : 340 (:i30 to 370) rrn:. Ni'iiet dQ idn: r,.i€c: "i7'L-.lihLrcrng pirrip do: Dr.,ng hqic. DC thu6c ihu'd' I 5-25 "C tiirrru liri sLi

.;urig.

STT Dd muc

1

1.1

1.2 i'"hong

1.3

1.4

&*'..q/lRlcHt'

={ cono,*\ aG

\$-"1

h4du: Hrrlet thanh h.ric heparin huydt iuong. Kh6ng sil ii*ng e ii,.iich6ng dOng m6u khric..l{hOng su'dung ci:,c miu tan m6ii. i.aJ ;;;iir pr:;ridu'rvc.thuc hiOn, t6t r:h6t, sau 8 gicr sau lin. cKNAC 5n dinh ii.*r:g rLriiriin d6n 7 :rgiry d 2-8'[' ua ;rl ngay d.-:0'C.

1.5 Ch0ng chi dinh !.-hdng su dung ngoii n:\rc,,Jich xit n8l:iem CK ^-a.C-r,:il=ii,-;;;.;;1.6 Cinh b6o vir th4n

trgngSan.phAm khdng rlurlc ph6;r il;;lhuoc thu'nen ducrc .:;,r 11 c:in than. thco thric hanh phorrr ihi-,ii:1i;-,,,rdt.Chfr ]y.: thLrdc thu ch*'a Sodium Azide i0.0q5%) ldrn ctrd;, bar., i1;;:in.'{ t | : ' ': i .!rfinn nil(rt \a ltep.\LtC \Or tja. mdt ra tiiint lnaC.

1.7 T6c dr;ng UAt tqlc6 th6 xhy ra

i.,hi de h5t han ghi r,ren vo i:iip.

2 Th6ng tin sin phAm dE luu hinh t4i c6c ntr6c 6il "6)Nu6c d5 pho duyqt cho phdp luu hdnh s6n phAm: c6ng cl6ng chung ch6u Au.

3 Chi tlinh tIf, {6ng ky & c6c nu6c khr6c (n6u c6)4 Th6ngtinv6${nh&i?toirnA.$rrh}rlrhcIringlrruvcria.a,pffi

H5rrg san xirSt dar IS0 13.485:1012 vd I:rO 9001:200gHdng hoa hodn tosr' r,6 hai viii con ngur;;

%Yeoffi'r'/ 4'l TRA(I{ I'llilEli ilUEi *Sttanext'

,;\ ecJAoDtr

vN pefrlN bx\*..*-.I

'tluru+ . r l

p khiu

+.l

crArur ooc

|J l1{|l

fTE

o.A, x,i FIot crga: N{;sgi r t ii.T c.'"\icoNc rY TNI*r CGNG II

cOruc NcnO i-rt ot ct,*o Dtic PQB Doc l6p - Tu do - [*4nh sria{rc

Sd: I I/NK-PeB l'p LIa t,-,, -iui i; ;;;;;;t i; - ,i;iti; -:ii,

TAI LIEU Kv THL 4T M0 rA CUUUG s,OAt TR.ANG TF{IilT BI Y TFl l\ H + :', ic ti .\ r11. Creatinine

90lo6i=\_{.j i,."\0ru0 lr-\, \ririiu rru iuu'iii NGHE YTfi } =;rAo nuc l:,affi /,giEaiy&=;rrr"'

STT D0 mgc f{Qi dung rn6 ti t6m tit1 MO te sin ph6rm trang ttri6t niy t6t.l MO ta h6a ch6t chAn

do6n dirng cho m6yx6t nghiQm sinh h6a

ChSt ihn chdn cloiln I reatinine du'a tr"€n nguy€n lf ilc d.r; i:;i;,. :iiu ith i

c6 su thay doi ma.r sic cua h6a ch6: sau khi trrin viyi hur'r,i ii:niii.Creatinirie phdrr {r'ng irong m0itruc'r;g Hem v6i picmte iii: 1;,i,,; r'l: r'::+i

hop chdt mau cuc'rg d0 ctra n6 tj'16 voi n6ng d0 crea;ii.rinr li.iilglnau.Rl: L.itirium hvdrrxicle 120.0 rnmoir'l-

Lio:-ic acid 8ti.(l rnnrr:l/LR2 Picric acid 67.0 mmoi/LBao cluan

" Bac q'iAn o nhiqit d0.1-5-25'C" xen: ngly h€t han tt*n hai; bi.

" Sau kiri mo nip. thridc thir 6n dinh dOn 90 ngil' *dir <jrlrrc 'iirrrg *ill:rle&) \;r duo.c bar, vd kh,ri nhi6m b"lr. hOc hoi. linlr:;.r:.. t:':. il.::",,,rluoc luu trfr'6'rlung niri*t dd bao qir;in.D6 6n c'inh cuadi.rngclich larn vi6c (R.1 r- tl2):7 ngar .i l:-li ,:-

1.2 Danh muc lirrli kidnvd phukiQn (k€ ca

h6a chdt di kei::)

KhOng

1.3 Muc dich/Chi ciinirsir dung nhiL giritr€n nh6m

clh6t thii chAn clc;in dc rr,ine dQ Creatini;re trong md;u

1.4 Hu6ng d6n s*'riung iloa chLit an toan Jd sLl di-r:rg.

Bu6'c siing do:)": 510 (500-550) nm. Ni.riQt dQ ldm viee : :17"{'.Phuong ph6p do: Pir-lm cd dinh.Miu: i-iuy6t tha-nh hodc irLrlz6t tuong" K^h6ng sir ciung *hat r!:'i:-ri.rtlong r,iu khdc. h.htirrq:.Ll dung ci. :ttiir tan ntatt. ( :;,i' :i:, ,,,: ,1 ,'.

i ," ,xtr'orrg niau l€n t'eli l-lh ti 2-8'C.

1.5 Ch6ng chi dinh I{h0ng sdr dung ngodi inuc dich xOt ngiri€rn Creatii:i*c ti'(-}ii:r ;i..,i..

ngu'o'i

1.6 C6nh b6o vd th4ntrgng

Sin.phiirn kh6ng iirro-c pirin loai li sar: ph6m ngul hi0m.'i'rii i'ri.riri',"

thu6c tiiu'n€n dui;c xir l- cdn thirr, tileo thr,rc hanh ph*r':g ii:: ;rghi'1r::

tot.Ch'i;,: :iiu6c thu'chfla Sr:dium Azicli: iC:.095%) lirm ci:.it i:ao.'irri.,i., : . .;Tr6rrl: riuot vd tier: rLic vrii da, m[t -.,:i rr;6m mac.

1.7 'I"6c dung bAt lr',i c6thd xiv ra

Khi dA h6t hpn ghi trdn vo hQp.

1 Th6ng tin sin phAxn dfl luu hdrnh t4i c6c nu6c (n6u c6)Nu6c dd ph6 duyQt cho ph6p lrru hdnh sAn phAm: CQng d6ng chung Chdu Au.

3 Chi tlinh il6 iting Ery tr cdc nu&c kh6c {n6u c6)

Th6ng tin vii tfnh an toirn/vfn hdnh tl6ng luu;f cfra sin ph6rn trang thiHdng s6n xu6t dat ISO 13485:2012vit ISO 9001:2008Hdng h6a hodn tohn v6 h7i v6'i con ngudi. )

ryw-wi gfl,rn,pT,i,io

b!y t€

v! nh$p khiu

ffi,**he / tRACltt{lllflttl HIJ[|1A|{ \]sti L*A1n uiu* vh{ \s*\ ".''I,'l)l':,:1" /*

e$ll* rv'rnAcHrnt$ult\tt4

t6uo Hcn$ Y

@

c0xc rY TNHrrcONc Ncnp Y rE c crAo DUC PeB

56: 1IINK_PQB

ceNC HoA xA mqt cuu ucruEe vr&,-'r N \irDQc l$p -'['u do - H4nh ;:i:ue

!'l Aai\qi, ngiq, l1 thdngilT ttr'ttr:7iii-

TAI LIEU KY THUAT MO TA CHUNG LOAI TRANG TT{IET BI Y TE NHAP KHAU

g!.rr(t\COt'tC n'\:

aH unrEN t.W rillrHc lrcnE y rE-

I crAo oucPOB

lifsj

12. CRPNQi dung md ti tdmtdt

MO tA sin phArn trang ttriCt fi y t6

ChAt thir chdrr do6n ClRt'}iu'a tr€n rrgu-r,'6n 11, do ctQ I':AJ: iiir; i'.i:: cii :,Lr

lhay d6i rndu s6c cua hoa ch6t sau khi tr0n v6'i huy'0t thai':ir. {li!c cl;aiphin fi';re CRF.le nriit huyin phir cua c6c hat latex polr,sl-r.;icile r:ii !';ri-rir

ihLLoc cl0ng nh6t pli,.-r l'di lgG anti-hur*an (-'RP. Kliinrot iiirii; cri ciniaCR.P chLoc trdn l6n r,o'i tiru'ic thu'. su ir5t t7p 16 rhng xe 'o r"a. eii ij:.],JrLcvc di; i:ang phip ,Jo dd .luc.tlRP R i ! ris hufie;' pH .8.2 20.0 mrnoiil

Sodium a;ide < {i.lo/o

aRP Rl Suspension ol'pclvstyrene la"ie.t parlicles coate(i iiiih 1g{l

anti-humen CRP. ir: a buffer .

Sodium azide <{i. l%Bao quan. [3ao qr:rin ir nhiQt r.iO 2-8'{i, xem ngi;r h'3t h4n tr6n bao i;i.* Sau khi mu n5p, ihuic rhir' 6n dinh di;: t$n h6t. han dr:;t.i' niu iiri'.-,i.:

rlong nap nga1, vi iiugc bao vQ khoi nhi0in bAn, b6c hiri. tit:ii sii::,: ii'iii:ti0p vd Cr-Loc luu trii rr Cirng nhiet d0 b;ro quin.

M6 ta h6a ch5tchAn do6n dirngcho m6y x6tnghiQm sinh h6a

Danh muc linhkiQn vd phu kiqii(kC cn hoa chit cli

kdm)

ChAt thu chAn do6rr clo rror-rg do CRP iio;rg m6uMr,ro dich/Chidlnh st dung nhughi tr6n nh6m

H6a ch6.t an todn de su'dung.llu6'c siing do: ),5,10 nrn.l.Jhi6t d6 ld;r riec: 37'C. Pitu'onu pirap iio:Do di€rn..ir45u: Liur,St thanh. {,-RP 6;: dinh trong miu lOn d6n 7 ng;i;' ii :-"{'i- .

Hudng d6n stdung

Ch6ng chi dinh Khdng s[r dung ngi.r,ii muc dich xdt nsliiim CRP tror:g miu ngiriri

San.phrinr kh6ng dL;"o-c phiin loai ld sdn prhAm nguy hidm. 'i u3, r.ri;ien.

rhue,c tiiu ndn cluirc xu'[1, i:6n thAn, theo tnuc h]rnh phcng tlri rrilhiir;-iIot.;'lrLi ):ihi,dc th[rcl,u'a \otiiurn Azitie,0.(]959o) lArn si;1 i:;;;r.;;'.iirr;

i-rrinh r:ui)t vd ti6p r[rc v0'i cla. mf,t vi: rri0*r rnac.

Cdnh b6o v?rthdntrons

Khi c16 lict han ghi tr€n vo hQp.Tric dung b6t lqic6 th6 xhv ra

Th6ng tin sin phim tIfl luu hhnh @i c6c nu6c (niiu c6)Nudc da ph6 duyQt cho ph6p luu hinh sAn phAm: CQng ddng chung ChAu Au.

STT Dir muc

1

1.1

\:i\kil./t't

1.2 Khdng

1.3

1.4

1.5

1.6

1.1

2

Chi tlinh tIfr el6ng k;f & c6c nrfc kh6c {niiu c6)

Th6ng tin vG tinh an tohn/v$n hinh tl6ng luu,y cria sin ph6rn trang ttriGt Uiy t6Hdng s6n xudt dpt ISO 13485:2012vit ISO 900f :2008Hdng h6a hodn todn v6 hai vdi con nguoi.

//;;

=/*\rO\\\,

CONG TYTRACH l{Hli}il lllju l1Al{

c0uc ucutYri& GIAO

PO

ciAvr poc

W-trii9'h,tu,gtrtd,

t ,t'

//s'

{;("[t= t ct

WX

c0Nc rY TNHHcONc xcnp, y rB e crAo DrJC peB

56: 1IINK_PQB

TAI LIEU KY THUAT MO TA CHUNG I,OAI4'RANG THIET N1V TN NH+F KHAU

cgNG HoA xa uglr cst ncr*ie vrr.r \,s-\;DQc if,i1 - T'qr do - H4nh p*ruc

Tp Hd Arfi, rgdy l1 thang i)7 ettiis; )ii!:

13. D bilirubin

l0loe i-\...".-)A\t{Ht;u ttul] h.Aii tr$NC|EyrE l*rAo duc /l'aa /#i;-{:Y-.F

STT D6 muc NQi rlung m0 ti t6m tit1 MO te sfln phArn rang thi6t biy tii1.1 M6 te h6a chdt

chAn dorin dirngcho m6y x6tnghiOm sinh h6a

i]hat thri cirdn doiir-i t Bilirubin dua trtln rgLrr,6n ly cio ii{; iriiJ,. iirr, j..ii,+,5 suthir', dOi mau i6c cira hira ch6t sal k:i tron vtii hri.r,,, tir'i:rii.iJilirLrbin l.r'Llc ti0p (.;onjr-lgatetl) phrin ei;rg i,cri axit sulfuriiic ya ,r..,, it,i::,Azocompound (azoirilirr-ibin). S"1r ting h6p thu do su hir,h ri:an1;rzobilirirhin ty 16 th:.rAn ,,,6'i n6ng dd biiirubin truc t.iCp tr.oi:!,r *iriu.R I Sulphanilicacid,l.2.0 nrrnol/l-

presr:ri,atives &rrd anionic surf'ace-active agentsil2 Nitriie'sodium G.35 r:rncil/Liiao qurn. Bao quai', cy nhiet eiO l5-25'C, xem ngdy h5t han tren bai; i:,i.. Sau khi rncr nEp, ihu6c thu 6n dinh it6ri 90 n-uav r:€u cfusr: di;nr r:ip;-rga! va clu'oc bao ve khoi nhiSm bAir. b5c hoi. dnh sirng r'iLrc tii:r r;iifuo-c luu tr[i'o diinSi nhiet de' bAo quin.Ilo 6n dinh cira dung dich idrn vi6c {R i -,' R2): l4 ngiir,ii ii,li'r,'.

t.2 Danh muc linhki6n vd phu ki€n(k0 ca h6a chdt rJi

kem)

(hdng

1.3 Myc dich/Chidlnh sri dung nhughi trdn nh6m

Ch6t thrle hAn doar: Jo nor.,g cl6 D Bili:'uoin trong r:rau. Tiii:g bliiri;hii:irong huy5t thanh bang:. biliruhir; kh6n-e lien htrp irLrdo) (Bul bi iirrqbuoc voi iiiit*:rii:;. bilirubir: lien hop iBc';" bilirubir: 5 (86) licn ket c,)ng hoa ti'i ,. oi alburnin.

.i' Bilirubin tru'c ticip lh0 516rr du'<yc ldm cing Bc vd 85. v*'i ;::r:t tj,ienho Bu

1.4 Huong din sftdung

ll6a chilt an todn d0 srlr dung.Budc song do: )": 5?0 (550- -580) nm. Niriet dQ ldni vi6c: 37"{.t"FIiu'crng pirap clo: D* cli,3m.

L4au: Hu-r'0t thanh hoic liu;r,0t tu'ong. Kh5;:g s0"durrg c;ic ;.i;ii: iiti: :;i;ii;.1.5 Ch6ng chi dinh (h6ng sil dung ngoai nruc dfch xdt nglii6ra D Bilirubin rroilq i;rrri

;-rgiroi

1.6 Cinh b6o vd thdntrgng

San.ph6n: khong drLirc phdir loai ld s6r; phim nguy hi6r::. 'lui, irliii*"

ihudc thri n6n dut,*c xu' i1,, cin thAn, theo rhuc hanh pitr)i-rg ti:i n5li:i..:rii1r)t.

{-lhu y: rhitOc thu cl"rrLa Soclii;m Azide {0.ii.)50,6) lanr cha i-::,, ,.:i.riiiri . .:

lrtinh l:trril va tiep rirc'r6i da, mat vd r:i6r.:'r mac.

1.7 Tdc dung UAt tqi, -,4co tne xav ra

Khi d0 h6r han ghi trOn v6 irrip.

Thdng tin sin ph6m dfl luu hirnh t4i cdc nudc (n6u c6)Nu6c dd phO duyQt cho ph6p luu hhnh sdn phAm: CQng d6ng chung Ch6u Au.

Chi tlinh ttfl tting trqi 6'cric n*6c kh6c (niiu c6)

W,trfii?l,ln,yffluio

Th6ng tin vijtinh an tohn/vfn hirnh il{ng luu;i cfra sin p}rAm trang ttrilit Ui y ttiHdng stn xu6t d4t ISO 13485:2012vir ISO 900J:2008Hdng h6a hodn todn vO h4i vdi con ngudi.

z'#q:{J.iiii5*/ r.firc r-v \i67 .\,\rI\.W l. I \'u:/ sii\u uufiti !tnr!AI \'-{/ IRACii t'{tllh?il ti"uilll1$ii \ f>l r.Aunu:uAvrr' lb*t "T':,'J:":l:;' j*Ie*xcrnnul{nltu

e&ffiilGtg 6laCI

\pe

ia\i1f,],lt4li

rr\v r,{

clAna ooc

Kf"'f,/rqctt

w

cONc rY TNHHcONc NGHE y rB c. crAo DUC peB

,56: I1A{K*PQB

ceNG HoA xA ngr cnu NcHia vrpr NAMDQc lap - Tq do - II4nh phric

rtgt\)t l1 thting{): nir:t )ii!lTo I{d Nr2i,

4a

TAI LIEU KY THU+T MO TA CHUNG LOAI{TRANG TX{IET BI Y TE NHAP KHAE]

PgIqsCONG TY \",cttHl"]tEu url1,t l4u

ruo NcHf v rE

i crAo oycP0s ,/,

Vr$,

14. G-GTNQi dung rn6 tA t6m tit

rn trang thi6t m!y tiiM6 ta h6a ch6tchAn do6n dirngcho m6y xdtnghiCm sinh h6a

Iiir t)n dinh cua dung dich lziin vi€c (Rl r- R2): l0 nga-r, ri ll-E"i'

ChAl thur chin do6n (;-C'f cJua tr6n nguy,6n lf do dQ hip'rhL: i<j:i cir sLL

tha-v- <16i in:iu sic cia n6a ch0t sau khitrir; v6'i huy0ltiiai:ir. Hiriir::Cirnrma-glr,iiam-yl ctu'.,c chu.en tu gar:rii..a-glutamyl-cart:ox-t,:;iiri:ill-t:i,iji;san g C lycl,g[1'ci ne ba n g gar: :maglutamr lt;'ilrsferase ("y-G'l ; lii rt, ri r.ri, ir.tac. Ty le t;ng hAp thrr ty 16 thudn veii haat dong crha miu v-c.j-[.R I Goods l.ruffer, pH 8.25 -:50.0 rnmoli i-

Ciyc-r lgiycine i 8i).0 ;lmolilR2 L--eamnra-glutam.,'l -3 -ca;"boxy-4n itic;a;t i I ide 2 0. 0 n: in,r ir'i .

l3ao qudn. l3ao quan ri nhiOt di 2-9",.. .rem rrgil l.ret harr trin bto ir," tlau khi i:ro'nip, tl':u6c thf 6n dlnh li€rr 90 n-uhy n0r-i iiiiiic iir;rr n;ipn;:a;- va diroc bao vi khdi nhi6m bdn. b6,c ho'i" 6nh sdn* ii.r'c;i..;: iiidLroc luu trii'o dirng nhiet d+ bdc qLrdn.

Danh muc linhki6n vd php kiQn

ft6 ca h6a ch6tdikdm)

Msc dfch/Chidinh sri dungnhu ghi tr6nnh6m

tlh6t thu'cl:dn dc6n (;i) t'lojtir. Co G-GT 1r',.-tr;s miu. G-CT rl :",,-i;iirt::;r.,,iT'i'ansf'erascl ld mdt eilzyme ireierodimelic nim o cuc c,:a mairg t--1a:-';.:-l;;' , .:. ;. .cua itltidt; ti bdc cc c;iuc nar:s tidt ha,' r:i1', rhrr ra o cuc iu'-r:;r i;rl:;J ti.bao 5ng than.

Hudng d5n sri'

dunglloa chAt a:i todn d0 sii cluns.tlir'6c sor:g rto:),:4G5 (400- 420) nm.l'.ni,Ar d6 ldm vi€c: -17"i. . i.li;:.iiri:.:pir6p do: Lr,;ng hgc. ti6 thuoc thu' cr l5-15 "C tru6'c khi si;: .jl:iig.Iv{5u: I-{u1,6t thanh hoiic ED'i-A huy6t tu'o'ng. Khdng sti ctur:g,,ri* ,',',,1,., i,,,',rnau. C-Gl'6n dinh tiong miu l€n d6n 7 ngdy 0 2-8'C.

Ch6ng chi dinh Khdng str'Gung ngoAl muc dich xdt nghi0rr G-GT trons n,.;ii.r ;;pliit-ri

Cinh b6o virthfln trgng

Siin.ph6nr i.-hdng duc,: phiir; ioai li sAn phiirn nguy hi€m. -l *;'r:!ri*;:.tl'ir6c th*'r;€n du'o'c xir l{ c6;i ti:An, thec ihri"c hdnii pirong iiri rir|:iiiii ri,i.ChI yi: thufrc thu'chirr SodiLrm Azide (0.095%) ldm chdr b;iii rli;::r.

I . .:I rirrh nuol va tiep xfic vtri da. mdt vd niint mac.

T6c dung b6t tqic6 thO xhy ra

h0t han g;hi tr*:r vo hiip.

Thdng tin srin phdxn {If; lru h*nh tai c*c nrro"c (n6u c6)Nu'6c dd phe dr:yet ci:o phd,p irru hanh s;n ptriii:: Cong cldi:g cnLlng Clhiiu ..iu.

STT DA muc

I1.1

1.2 I(irong

1.3

1.4

1.5

1.6

1.7

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<J-e/r<, z.-i.J--. t

4 Thdng tin vG tinh am toin/v$n hinh tL{ng luu f cria sin ph6rn trang thi6t ni y t6HEng sin xuAt dat ISO 13485:2012 vit ISO 9001.:2008Hdng h6a hodn todn vd hpi v6i con ngudi.

#*+7c0No tf .\?^qAiiH-nnri,uutruSY;={ cbuoNGHE\ lf l**\ - I nrio DtJut /'d

gdNc-,f$Wq

K,r'A

W

cONc rY TNHHcONc NGrrE, v rr c crAo DUC PeB

56: l I,NK-PQB

ciJNG HoA xA xaqrt cntt ru*;rg:i.e, z,i;j 'I \ ,"\, !

DQc I$p - Tu do - Efpntu grirrle

7-pHdN"6i, ng;a1, ll thdn;1{)7 r;ii;',s Jiii')

TAI LIEU KY THUAT MO TA CHUNG I.OAI{TR.ANG TI{IST BI Y TE NHAP KHAU

9191t\..1rupw\$nrEurt.tuint\?'HcgEvrr i-Aoduc l:'as /;%;iy

15. Glucose

NQi dung md ti t6m titMO te sin phim trang ttri6t niy t6

Clhit thu'chAr: dofn Clucose clua trCn nguy6n iy do Ji i:iir'riri;khi co su tha-.,' d6i nrau sic c0a htia chAt sau t hi i;'on i,-'i rrr; i'ttiranh.R I ['hosphate bui'ter pH 7 .4 10(i.0 rnrnol/L

Phenol9.ii mmai/i-GOD > 2i000 tiill,oD > 1:u0 LI/l4-aminopiienazo:re 2.3 mmcl/1.

Ea() quan. flao quan c nhi0t de 2-8'C. xein ngiy'h€t han iri'r:.i:rrc; br.. Sau khi rro':r5p, thuOc th{r'6n rlinir ddn 90 nga'r' ;tir iiilirc .ii,t,.:.-,nap ngayvatiuqrc bao v€ khoi nhi,i:rr bin, bdc lrivi.;l:ir s;!::'; jl:iti0p vd duo-c iiru trfr'o'dfng nhi*t tjQ bao quAn.

MO ta h6a ch6t chrindo6n dilng cho miiy:<itnghi0m sinh hoa

Danh muc linh ki0n vdphu ki6n (ke ca h6a e,hitdi kdm)

Muc dich/Clii cli*h sr;'

dung nhu ghi trerr nhrin.r

('hir: thr:' cLi6rr doin 'to nong cio lllr cclsr- trong r*:r:

Hu6ng d6n su'dLing Iiiia chdt an t{ran dd su dung.BLriic s6ng dc: ),.: 5 iG 1500-550.) nrn. Nhi6t d6 larn vii,:: .i7''i .

Phuu,ng phSp do: i)c di6m. D6 iiru6c thu'o' l5-2:{'C ir*ri'c iti:;sii'dung.MEu: Huy6t ti-ranh hodc EDTA huyiit tuong. Khdng sil'dung c6c

nrii.t tan mau Gluco:e on dinh i,ottr tniu l0n d6;i.i r:r;iv r;,1-8"C"

Chdng chi dinh Kirr)ng su'duirg ngoiri n-iuc dich .<dt nghiCm Giucrse ili-)iri:, ;i'iaiinguoi

Cdnh b6o vd thdn trong rAm nguf i:iqn;. 1 irlniii'3n. thuOc lirli'n0n duo-c xir l1,'ciin th6n, thec th*'i, i';ii;:li i:lir;:1,

:tlr: rrgh rem toi .

('hri y: thuerc ilitr chiia.sodium .r,zrcle (0.095%) ilr:"i ,-lii i-,r,,i,

qriirrr. 'l'r6nh rru6t va-li6p xirc vc'i cia. mit vd ni6m rr'i;rr:.

T6c dung bdt lqi e6 th6xAv ra

Kha de h6t ira.n ghi trin vo hQp.

Th6ng tin sin phinre dE luu }ainh t4i cf:c nrrd;'c (n6u co)Nuric d6 ph0 rJLr,r,et ciio phip liru hanh sd:: pirArr:: C6ng c16r:g;hung Chiu .!u.

Chi ilinh ilfl dlng \f & cric nufc khric lnilu c6)

4 | fnOng tin vO tinh an toin/vQn hhnh rl6ng luu y cfra sin ph6rn trang ttri6t Ui y t6Hdng s6n xu6t tJat IS0 I 3485:2012 vd ISo 900 i :2008Hdng h6a hodn toiln r,6 hai v6'i con nguiri.

,/lrfln,/in trli gfl,,ld,rfl ffluio

ffiv/"YcbNr'l TRACl,i lllill

F{ c0uc ur

,;\ & GrA

N+\ P(6x------1\:-"1{G " 1.

1>\\\z\r \',' l'.

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cbuo rYmlcn rutilttitru na|{

c0ruc HctitV tE-

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