Anti-D Monoclonal - IgM - India CDSCO Medical Device Registration

Anti-D Monoclonal - IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_67625441fb2718e3fa1c2d9264767607_adf27db7635c4ea94ca4edbd478a365e. This device is marketed under the brand name Poly Specific. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Anti-D Monoclonal - IgM

UID: MFG/IVD/2019/000025_67625441fb2718e3fa1c2d9264767607_adf27db7635c4ea94ca4edbd478a365e

Brand Name

Poly Specific

License Holder

ARKRAY HEALTHCARE PVT. LTD.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

SPANCLONE Anti-D (Poly Specific) Monoclonal IgM antibody (Poly Specific) is an agglutinating antiserum for detection of D (Poly Specific) antigen on human red blood cells

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