Hauv Vitro Diagnostics

Jan 06, 2017

Tso lus

Hauv vitro diagnostics thiab IVD (In Vitro Diagnosis), yog hais txog sab nraud ntawm lub cev, los ntawm cov tib neeg kuaj (xws li ntshav, lub cev kua cev, ntaub so ntswg) rau kev kuaj thiab nkag mus rau cov lus qhia, cov khoom thiab cov kev pab cuam thiaj li txiav txim tau kab mob los yog lub cev tsis muaj zog.

Internal nyob rau hauv vitro diagnostic (IVD) kev loj hlob pib lig, kom txog 1985 tsim Tuam Tshoj lub thawj cov khoom ntawm kev tshawb fawb ntawm cov tshuaj lom kabmob. Tab sis tau txais kev pab los ntawm kev noj qab haus huv, nce qib kev noj qab haus huv, lub xeev cov kev cai txhawb nqa, thiab nws tus kheej muaj cov yeeb yam uas siv, uas yuav 15% ~ 20% ntawm qhov kev lag luam IVD. IVD (In Vitro Diagnosis), Suav txhais lus rau hauv vitro diagnostics, hais txog sab nraud ntawm lub cev, raws li kev kuaj ntawm tib neeg lub cev (ntshav, cev kua cev, ntaub so ntswg, thiab lwm yam) tau txais tshuaj ntsuam xyuas cov khoom thiab cov kev pab, nrog rau cov tshuaj reagents, reagent khoom thiab calibration cov ntaub ntawv, tswj khoom, Khoom siv, twj, cuab yeej, khoom siv los yog tshuab. Raws li Tuam Tshoj Lub Xeev Khoom Noj thiab Tshuaj Tiv Thaiv (SFDA) ntawm cov khoom siv kho mob tsom xam cov txheej txheem tsom xam cov tshuaj ntsuas kev soj ntsuam-6840 ntawm chav kawm.