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CDSCO UID IMP/IVD/2020/000732_621e692735eb2eca70e7dd894ab838f3_5649400a0db4007d439f4f0a89f47a00

D- Dimer

M/s GENWORKS HEALTH PRIVATE LIMITED., ,Survey No.479/1, 479/2, 479/3, 479/4, 480/1, 480/2, PHASE 2, EAST FACING, GROUND FLOOR, SCHOOL ROAD, KATRAMBAKKAM-602117, Sriperumbudur Taluk, Kancheepuram District, Tamil Nadu. ,Kanchipuram Tamil Nadu ,602117 ,India·Device Class Class C·India CDSCO·Brand: CLIA
Registration details
UID
IMP/IVD/2020/000732_621e692735eb2eca70e7dd894ab838f3_5649400a0db4007d439f4f0a89f47a00
Device class
Class C
Brand name
CLIA
License holder
M/s GENWORKS HEALTH PRIVATE LIMITED., ,Survey No.479/1, 479/2, 479/3, 479/4, 480/1, 480/2, PHASE 2, EAST FACING, GROUND FLOOR, SCHOOL ROAD, KATRAMBAKKAM-602117, Sriperumbudur Taluk, Kancheepuram District, Tamil Nadu. ,Kanchipuram Tamil Nadu ,602117 ,India
Approving authority
CDSCO
Product information
The kit is an in vitrochemiluminescence immunoassay for the quantitative determination of D-Dimer in human plasma using the MAGLUMIseries Fully-autochemiluminescence immunoassay analyzer (CLIA).,hs-cTnl (CLIA)(CLIA)-The kit is an in vitrochemiluminescenceimmunoassay for the quantitative determination of cardiac Troponin I(CLIA)in human serumandplasmausing the MAGLUMIseries Fully-autochemiluminescence immunoassay analyzer (CLIA)
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About this record

D- Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000732_621e692735eb2eca70e7dd894ab838f3_5649400a0db4007d439f4f0a89f47a00. This device is marketed under the brand name CLIA. The license holder is M/s GENWORKS HEALTH PRIVATE LIMITED., ,Survey No.479/1, 479/2, 479/3, 479/4, 480/1, 480/2, PHASE 2, EAST FACING, GROUND FLOOR, SCHOOL ROAD, KATRAMBAKKAM-602117, Sriperumbudur Taluk, Kancheepuram District, Tamil Nadu. ,Kanchipuram Tamil Nadu ,602117 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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