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#*,ffiffiyro CQNG lI0A xA HQI csu NCuia vlgr Naur


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vA viQc ban hinrr da,h -$Ylmfii{rfl


bi y td chAn do6n,in,vitro
xit nghi$m kh{ng nguyon SARSICoY-z iugc cdp s6 dxng kf

Bq IRtIOT{ctr0 Y TE
Cdn c,* Nghidinh sii rctZOt6/NE-CP ngAy t5/5/2A16 cila,Ch,inhphi,va qudn
l! trang thi6t biy t€;
Cdn eir Nghi dinh sA rctZO t 7/ND-CP ngqy 20/6/201 7 cia Chinh pkil qay dinh
chttc ndng, nhiQmry, quyin'hqn,vd co ciiu d ch*c crta B0 Y t€;
Cdn,cti Nehi dinh sd 169/2018/ND:CP ngdy 31/l2l20l8.crta'Chinh,plti s*a
ddt, bd sungmgt-sii itiiu daNSh.i dinhs6 36/2016/ND-CP ngdy 15/5/2016 cfia,Chinh
ph* vi qudn ly trang thiht bi Y tii;
. Cdn 9* Nghi dinh si| 0;/2020/ND-CP ngdy 0t/0t/2020 cng'Cliy\rh1i"s*y da_i,
bd t".s-di;;
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doan in vitro x6t nghiQm ilinh tinh kh6ng nguyCn SARS-CoV-2 duqc c$p s0 dlng ki
trong truong harp cdp dO phdng chting dich COVID-l9. 36 dang kf.c6 giilti L2
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tr6ch nhiQm: \
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Y t6 vd phdi ilim b6o th6ng tin'dAy dtr, chinh xic vd sin phAm tr6n nhdn, trong tdi liQu
kdm theo trang thi6t bi y:i.*"
quy.dlnh cria ph6p lu$t,v0 nhdn hing.h6a;
2. Chiu tr6ch,nhiQifr vd ch6t luqng trang thitit-bi y tti duqc c6p,s6 ding lcj', dim
bio ch6t lugng x6t nghiQm vi b6o m$t th6ng tin bao gdm,c6c c6ng.sr.llnli.torln,ph$n
tich sO liQu;

, 3. Lpp, duy tri,hd.so,theo.d6i trang thi6t bi'y ti5 vd,thpc hign,truy xuit.ngu6n
g6c trang thi€t bi y t0;

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