CMV PCR Kit - India CDSCO Medical Device Registration

CMV PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001064_ff942d464166a8f0e72188e9de0fa267_9fe9cf3f25e8abe1e4777b140692a9b0. This device is marketed under the brand name AltoStar®. The license holder is Altona 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

CMV PCR Kit

UID: IMP/IVD/2020/001064_ff942d464166a8f0e72188e9de0fa267_9fe9cf3f25e8abe1e4777b140692a9b0

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The RealStar® CMV PCR Kit 1.0 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of cytomegalovirus (AltoStar®) specific DNA in human EDTA plasma and EDTA whole blood

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Purification Kit 1.5

Brand: AltoStar®

Altona Diagnostics India Pvt. Ltd.

CMV PCR Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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