Prothrombin Time Reagent Kit - India CDSCO Medical Device Registration

Prothrombin Time Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001094_d4df91a91fe52e6c140d19d30c607a98_7fa771a9fadffe00d93c9eefeaa9ea56. 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

Prothrombin Time Reagent Kit

UID: IMP/IVD/2020/001094_d4df91a91fe52e6c140d19d30c607a98_7fa771a9fadffe00d93c9eefeaa9ea56

License Holder

PTS Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Prothrombin Time Reagent Kit is intended to measure the prothrombin time ##PLACEHOLDER_0## of human serum. Clinically, it is mainly used to screen the extrinsic deficiencies of coagulation system and monitor oral anticoagulant treatment. With prolonged PT, there may be inherited factor II, V, VII, X deficiencies and hypofibrinemia ##PLACEHOLDER_0##; the lacking of acquired coagulation factor is found in DIC, primary fibrinolysis hyperactivity, and obstructive jaundice and vitamin K deficiency; with shortened PT, there may be inherited factor V excess, oral contraceptives, hypercoagulability and thrombotic diseases