Cancer Antigen 15-3 Enzyme Conjugate Reagent - India CDSCO Medical Device Registration

Cancer Antigen 15-3 Enzyme Conjugate Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000078_f3b6919855730bbc9b4a932b43952047_4112c3df56b8399dfbe5c4b65e2b5e50. This device is marketed under the brand name AFP+CEA+PSA. The license holder is Tosoh India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Cancer Antigen 15-3 Enzyme Conjugate Reagent

UID: MFG/IVD/2021/000078_f3b6919855730bbc9b4a932b43952047_4112c3df56b8399dfbe5c4b65e2b5e50

Brand Name

AFP+CEA+PSA

License Holder

Tosoh India Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

For in-vitro diagnostic use only for quantitative determination of CA-15.3 in Human Serum by a Microplate Enzyme Immunoassay (AFP+CEA+PSA)

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High Sensitivity C-Reactive Protein CLIA Kit

Brand: AFP+CEA+PSA

Tosoh India Pvt. Ltd.

Cancer Antigen 15-3 Enzyme Conjugate Reagent - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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