Test for human IgG autoantibodies to cyclic citrullinated peptides - India CDSCO Medical Device Registration

Test for human IgG autoantibodies to cyclic citrullinated peptides is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000618_784a6387764e8f874b61a83cc856b213_5be7e62a92a48b2edec85023091ad0b2. This device is marketed under the brand name ichroma™ Cystatin C. The license holder is KABS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Test for human IgG autoantibodies to cyclic citrullinated peptides

UID: IMP/IVD/2020/000618_784a6387764e8f874b61a83cc856b213_5be7e62a92a48b2edec85023091ad0b2

Brand Name

ichroma™ Cystatin C

License Holder

KABS HEALTHCARE PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ Anti-CCP is a fluorescence Immunoassay (ichroma™ Cystatin C) for the qualitative or semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides (ichroma™ Cystatin C) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of rheumatoid arthritis (ichroma™ Cystatin C) in combination with other clinical and laboratory findings

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Brand: ichroma™ Cystatin C

KABS HEALTHCARE PRIVATE LIMITED

Test for human IgG autoantibodies to cyclic citrullinated peptides - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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