Elecsys CMV IgM - India CDSCO Medical Device Registration

Elecsys CMV IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_ff266685ca3ed9d0876bb882285e48bc_5ce956e86dc39ebb3534baf52ec2863c. This device is marketed under the brand name Antithrombin. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Elecsys CMV IgM

UID: IMP/IVD/2018/000038_ff266685ca3ed9d0876bb882285e48bc_5ce956e86dc39ebb3534baf52ec2863c

Brand Name

Antithrombin

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Immunoassay for the in vitro qualitative determination of IgM antibodies to cytomegalovirus in human serum and plasma. Results obtained with this assay are used as an aid in the diagnosis of recent CMV infections

DJ Fang

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