Activated Clotting Time Reagent Kit - India CDSCO Medical Device Registration

Activated Clotting Time Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000278_82933f7d85ca33aec26b2e6a030b7a7b_667a2c1985e2021d20e872a94af65303. This device is marketed under the brand name CEA. The license holder is RAPID DIAGNOSTIC 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

Activated Clotting Time Reagent Kit

UID: IMP/IVD/2020/000278_82933f7d85ca33aec26b2e6a030b7a7b_667a2c1985e2021d20e872a94af65303

Brand Name

CEA

License Holder

RAPID DIAGNOSTIC PVT. LTD.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Activated Clotting Time Reagent Kit (CEA) is intended to be used along with Optical Coagulation Analyzer (CEA) for quantitative measurement intended to provide measurement of the time in seconds required for a clot to form in citrated venous whole blood which has been exposed to surface activator