D-Dimer Detection Kit - India CDSCO Medical Device Registration

D-Dimer Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000225_6e33f9b5f23b05e68940b175999dd715_e58befb22493a1c27855a344265edec3. This device is marketed under the brand name Nephelometry. The license holder is DIATEK HEALTHCARE 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

D-Dimer Detection Kit

UID: IMP/IVD/2020/000225_6e33f9b5f23b05e68940b175999dd715_e58befb22493a1c27855a344265edec3

Brand Name

Nephelometry

License Holder

DIATEK HEALTHCARE PVT LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

For in vitro determination of D-Dimer

DJ Fang

MedTech Regulatory Expert

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