APTT/PT/TT/FIB Reagent Kit - India CDSCO Medical Device Registration

APTT/PT/TT/FIB Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001094_d7867505c4cf4bb546c7ca1532d28506_e43c8baa19b93612fd8838159da04331. This device is marketed under the brand name PT. The license holder is PTS Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

APTT/PT/TT/FIB Reagent Kit

UID: IMP/IVD/2020/001094_d7867505c4cf4bb546c7ca1532d28506_e43c8baa19b93612fd8838159da04331

Brand Name

License Holder

PTS Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The APTT/PT/TT/FIB Reagent Kit is intended to measure the activated partial thromboplastin time (PT), prothrombin time (PT), thrombin time (PT) and quantitatively determine fibrinogen (PT)