H.Pylori IgM ELISA - India CDSCO Medical Device Registration

H.Pylori IgM ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_b6edc62e4aa8e5baf7fe94e593b54887_a73af5d3c99b249edb4032978cbaa7e4. 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 IgM ELISA

UID: IMP/IVD/2021/000083_b6edc62e4aa8e5baf7fe94e593b54887_a73af5d3c99b249edb4032978cbaa7e4

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 IgM antibodies in Human serum or Plasma by Microplate Enzyme Immunoassay