HemosIL Direct Thrombin Inhibitor Assay - India CDSCO Medical Device Registration

HemosIL Direct Thrombin Inhibitor Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000615_fd27a76e6e3a9070b9a263cfd7eaa909_63749530d4db78c6293912db76b54177. This device is marketed under the brand name HemosIL. The license holder is Instrumentation Laboratory 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

HemosIL Direct Thrombin Inhibitor Assay

UID: IMP/IVD/2020/000615_fd27a76e6e3a9070b9a263cfd7eaa909_63749530d4db78c6293912db76b54177

Brand Name

HemosIL

License Holder

Instrumentation Laboratory India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The HemosIL Direct Thrombin Inhibitor (HemosIL) Assay is an in vitro diagnostic assay for the quantitative determination of the Direct Thrombin Inhibitor Dabigatran in citrated human plasma on the ACL TOP Family of analyzers. The product is intended to be used for the measurement of active Dabigatran levels in situations where measurement is warranted