HIV RT-PCR Kit 1.5 - India CDSCO Medical Device Registration

HIV 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_c4a89fab74a9b752a5d0a94d6a1931f9_7d420409467c50ac6ed4340254bf03cd. 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

HIV RT-PCR Kit 1.5

UID: IMP/IVD/2020/001064_c4a89fab74a9b752a5d0a94d6a1931f9_7d420409467c50ac6ed4340254bf03cd

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The AltoStar® HIV RT-PCR Kit 1.5 is an automated in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human immunodeficiency virus type 1 (AltoStar®) specific RNA in human EDTA plasma. It is configured for use with the CFX96™ Deep Well Dx System (AltoStar®) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5. The AltoStar® HIV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in HIV infection. The results generated with the AltoStar® HIV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HIV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques

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Brand: AltoStar®

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HIV RT-PCR Kit 1.5 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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