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Dab tsi yog qhov khoom hauv vitro diagnostic (IVD)?

Sijhawm: 2024-02-29 Ntaus: 28

Kev txhais kom meej: Cov khoom siv tshuaj ntsuam xyuas hauv vitro yog cov tshuaj reagents, cov cuab yeej, thiab cov tshuab tsim los siv rau kev kuaj mob lossis lwm yam mob, suav nrog kev txiav txim siab ntawm lub xeev kev noj qab haus huv, txhawm rau kho, txo, kho, lossis tiv thaiv kab mob lossis nws cov sequelae. Cov khoom zoo li no yog tsim los siv rau hauv kev sau, kev npaj, thiab tshuaj xyuas cov qauv coj los ntawm tib neeg lub cev.

Regulatory Authority: IVDs yog pab kiag li lawm raws li tau hais tseg hauv tshooj 201(h) ntawm Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce, thiab tej zaum kuj yog cov khoom siv roj ntsha raws li Tshooj 351 ntawm Txoj Cai Pabcuam Kev Noj Qab Haus Huv Hauv Pej Xeem. Zoo li lwm yam khoom siv kho mob, IVDs raug tswj xyuas ua ntej thiab tom khw. IVDs feem ntau kuj raug muab faib ua pawg raws li Kev Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Kom Zoo (CLIA '88) ntawm 1988.

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Tom ntej: KEV CEEB TOOM

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