Pure Global

D- Dimer - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
D- Dimer
UID: IMP/IVD/2020/000732_621e692735eb2eca70e7dd894ab838f3_5649400a0db4007d439f4f0a89f47a00

Brand Name

CLIA

Device Class

Class C

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)

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from 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
Products from the same license holder (8 products)