Anti-D IgM(NOVACLONE Anti-D IgM + IgG Monoclonal Blend ) - India CDSCO Medical Device Registration

Anti-D IgM(NOVACLONE Anti-D IgM + IgG Monoclonal Blend ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000792_cbfa5fabcbab819b08edde2ef6ce06ec_55b2bd2b1dd7a0f4f6c251169c9801ba. This device is marketed under the brand name NOVACLONE Anti-A Murine Monoclonal. The license holder is Immucor India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Anti-D IgM(NOVACLONE Anti-D IgM + IgG Monoclonal Blend )

UID: IMP/IVD/2020/000792_cbfa5fabcbab819b08edde2ef6ce06ec_55b2bd2b1dd7a0f4f6c251169c9801ba

Brand Name

NOVACLONE Anti-A Murine Monoclonal

License Holder

Immucor India Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

NOVACLONE™ Anti-D IgM + IgG Monoclonal Blend is a “low protein” Blood Grouping Reagent used to detect the Rh D (NOVACLONE Anti-A Murine Monoclonal) blood group antigen on human red blood cells by direct and indirect hemagglutination tests. The test used with these Blood Grouping Reagents is based on the principle of direct hemagglutination