HemosIL Factor V Leiden - India CDSCO Medical Device Registration

HemosIL Factor V Leiden is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000615_c5d46e6ec29bc2105f954213257774df_bbd294da28152f1785719e7451945931. 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 Factor V Leiden

UID: IMP/IVD/2020/000615_c5d46e6ec29bc2105f954213257774df_bbd294da28152f1785719e7451945931

Brand Name

HemosIL

License Holder

Instrumentation Laboratory India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

For determination of resistance to activated Protein C, caused by the Factor V:Q 506 (HemosIL) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant(HemosIL) or heparin therapy