Anti-HBc (MAGLUMI® Anti-HBc ) - India CDSCO Medical Device Registration

Anti-HBc (MAGLUMI® Anti-HBc ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000036_ce169a1c31c64cdc8d73767f91b78ba3_8fc5e6756c42c0b1f9caaf99ee0e3090. This device is marketed under the brand name CLIA. The license holder is SNIBE DIAGNOSTIC (India) Private Limited., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Anti-HBc (MAGLUMI® Anti-HBc )

UID: IMP/IVD/2023/000036_ce169a1c31c64cdc8d73767f91b78ba3_8fc5e6756c42c0b1f9caaf99ee0e3090

Brand Name

CLIA

License Holder

SNIBE DIAGNOSTIC (India) Private Limited.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The kit is an in vitro chemiluminescence immunoassay for the qualitative determination of Anti-HBc in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System, and the assay is used as an aid in the diagnosis of HBV infection and for screening of blood donations.

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Anti-HBc (MAGLUMI® Anti-HBc ) - India CDSCO Medical Device Registration

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