SARS-CoV-2 RT-PCR Kit 1.0 - India CDSCO Medical Device Registration

SARS-CoV-2 RT-PCR Kit 1.0 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000143_ca7c11ff696610bd76404b8cec2dc64d_d04fc654dbb1d05d547c3438b83fbfb5. 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

SARS-CoV-2 RT-PCR Kit 1.0

UID: IMP/IVD/2020/000143_ca7c11ff696610bd76404b8cec2dc64d_d04fc654dbb1d05d547c3438b83fbfb5

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is a reagent system, based on real- time PCR technology, for the qualitative detection and differentiation of lineage B-betacoronavirus (AltoStar®) and severe acute respiratory syndrome coronavirus 2 (AltoStar®) specific RNA

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Brand: AltoStar®

Altona Diagnostics India Pvt. Ltd.

SARS-CoV-2 RT-PCR Kit 1.0 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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