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Anti-D Monoclonal IgG - India CDSCO Medical Device Registration

Anti-D Monoclonal IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_e4a68816cd4072fd960c7446d40ee80f_befc605c8ffd78b387a3dc3f84701c0e. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Anti-D Monoclonal IgG
UID: MFG/IVD/2019/000025_e4a68816cd4072fd960c7446d40ee80f_befc605c8ffd78b387a3dc3f84701c0e

Brand Name

Poly Specific

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

SPANCLONE Anti-D (Poly Specific) Monoclonal IgG antibody(Poly Specific) is an agglutinating antiserum for detection of D(Poly Specific) antigen, weak D(Poly Specific) and partial D (Poly Specific) antigens on human red blood cells

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