Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - India CDSCO Medical Device Registration

Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001064_1cff6d7ba87686e08eb4e60d4b4e88f2_036185b3c053d35d9d146eb236129bd9. 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

Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

UID: IMP/IVD/2020/001064_1cff6d7ba87686e08eb4e60d4b4e88f2_036185b3c053d35d9d146eb236129bd9

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of norovirus genogroup I (AltoStar®), norovirus genogroup II (AltoStar®) and rotavirus specific RNA in human stool specimens. It is intended to be used as an aid for diagnosis of norovirus and rotavirus infection. The results generated with the FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.

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Brand: AltoStar®

Altona Diagnostics India Pvt. Ltd.

Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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