High Sensitivity C-Reactive Protein ELISA - India CDSCO Medical Device Registration

High Sensitivity C-Reactive Protein ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_f9ae670e379a8626b0b6ec22a58e1a04_8071be4d4a2b968a57be4c8ff52ff592. 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

High Sensitivity C-Reactive Protein ELISA

UID: IMP/IVD/2021/000083_f9ae670e379a8626b0b6ec22a58e1a04_8071be4d4a2b968a57be4c8ff52ff592

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 C-Reactive Protein (CA 19-9) concentration in Human serum or plasma by a Microplate immunoenzymometric assay

DJ Fang

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