Purification Kit 1.5 - India CDSCO Medical Device Registration

Purification Kit 1.5 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001064_f5e79980bd63699eaa3e12ca6e767ae3_2a1982eaea06fccdb7194a3ced70513f. 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

Purification Kit 1.5

UID: IMP/IVD/2020/001064_f5e79980bd63699eaa3e12ca6e767ae3_2a1982eaea06fccdb7194a3ced70513f

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The AltoStar® Purification Kit 1.5 uses magnetic particle technology and is intended to be used for the automated isolation and purification of nucleic acids from specified human specimens for in vitro diagnostic purposes. The product is designed for use with the AltoStar® Automation System AM16, the AltoStar® Internal Control 1.5 and altona Diagnostics kits and reagents specified for use with the AltoStar® Purification Kit 1.5. The AltoStar® Purification Kit 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.

Purification Kit 1.5 - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

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