Tumor Marker Quality Control Material - India CDSCO Medical Device Registration

Tumor Marker Quality Control Material is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_cbe6b02b625da44ccc5ccf2793502441_3665bdb7fcb71b7858324e372278ebc8. This device is marketed under the brand name CA 19-9. The license holder is HAPTEN BIOSYSTEMS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Tumor Marker Quality Control Material

UID: IMP/IVD/2021/000083_cbe6b02b625da44ccc5ccf2793502441_3665bdb7fcb71b7858324e372278ebc8

Brand Name

CA 19-9

License Holder

HAPTEN BIOSYSTEMS PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The tumor marker panel control is intended for use as an assayed quality control material to monitor the consistency of performance of laboratory test procedures associated with determination and monitoring of the tumor marker status