AltoStar HAV RT-PCR Kit 1.5 - India CDSCO Medical Device Registration

AltoStar HAV RT-PCR Kit 1.5 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001064_e7494cd2b340565d44eca594dcdde867_1f8a00d4bf280f597bbb211789f77e31. 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

AltoStar HAV RT-PCR Kit 1.5

UID: IMP/IVD/2020/001064_e7494cd2b340565d44eca594dcdde867_1f8a00d4bf280f597bbb211789f77e31

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The AltoStar® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of hepatitis A virus (AltoStar®) specific RNA in human plasma. It is intended to be used as an aid for diagnosis of HAV infection. The results generated with the AltoStar® HAV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HAV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular Biological techniques and in vitro diagnostic procedures

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CMV PCR Kit

Brand: AltoStar®

Altona Diagnostics India Pvt. Ltd.

AltoStar HAV RT-PCR Kit 1.5 - India CDSCO Medical Device Registration

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Approving Authority

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