Anti-SS-A - India CDSCO Medical Device Registration

Anti-SS-A is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_cdb99da034432140722dbb4a827975d8_7a1e3787a89058ae0e4fb3c2046663d2. This device is marketed under the brand name Orgentec. The license holder is Weldon Biotech India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Anti-SS-A

UID: IMP/IVD/2020/000084_cdb99da034432140722dbb4a827975d8_7a1e3787a89058ae0e4fb3c2046663d2

Brand Name

Orgentec

License Holder

Weldon Biotech India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-SS-A is an ELISA test system for the quantitative measurement of IgG class autoantibodies against SS-A (Orgentec) in human serum or plasma. This product is intended for professional in vitro diagnostic use only

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Anti-SS-A

M/s Vishat Diagnostic Pvt Ltd.

Anti-SS-A - India CDSCO Medical Device Registration

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