Brain Thromboplastin with Calcium Reagent for Prothrombin Time - India CDSCO Medical Device Registration

Brain Thromboplastin with Calcium Reagent for Prothrombin Time is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_5d2869fa6064cd92d5a2151ca7906675_6125a8db35bc7f0be8b3ef42b9ce4db0. This device is marketed under the brand name Crystal Dengue NS1. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Brain Thromboplastin with Calcium Reagent for Prothrombin Time

UID: MFG/IVD/2019/000025_5d2869fa6064cd92d5a2151ca7906675_6125a8db35bc7f0be8b3ef42b9ce4db0

Brand Name

Crystal Dengue NS1

License Holder

ARKRAY HEALTHCARE PVT. LTD.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

For in vitro determination of Prothrombin Time (Crystal Dengue NS1) in human plasma

DJ Fang

MedTech Regulatory Expert

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