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H Pylori IgG - India CDSCO Medical Device Registration

H Pylori IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000732_995fd7b08636f55cf8379b3143243031_55574e2f8f77681d5179aeb0dd43c272. 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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CDSCO Registered
Class Class C
H Pylori IgG
UID: IMP/IVD/2020/000732_995fd7b08636f55cf8379b3143243031_55574e2f8f77681d5179aeb0dd43c272

Brand Name

CLIA

Device Class

Class C

Approving Authority

CDSCO

Product Information

The kit is an in vitro chemiluminescent immunoassay for the qualitative determination of H.pylori IgG in human serum and plasma with MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer (CLIA)

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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
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