H.Pylori IgG CLIA - India CDSCO Medical Device Registration

H.Pylori IgG CLIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_c20a6b87e14c6a3864a65e024dcc6fa4_6d8477b4ecaadeff06730f83dec5124b. This device is marketed under the brand name CA 19-9. The license holder is HAPTEN BIOSYSTEMS PRIVATE LIMITED, 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 CLIA

UID: IMP/IVD/2021/000083_c20a6b87e14c6a3864a65e024dcc6fa4_6d8477b4ecaadeff06730f83dec5124b

Brand Name

CA 19-9

License Holder

HAPTEN BIOSYSTEMS PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

For the quantitative determination of Anti-H.Pylori specific antibodies of the IgG antibodies in Human serum or plasma by a Microplate chemiluminescence immunoassay