PROTHROMBIN TIME RT & POC

Primary DI

D-02B0006YM

Basic UDI-DI Code

B-02B0006YM

Reference

1S001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The Prothrombin Time Reagent Kit is intended to measure the prothrombin time (PT) 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 (or afibrinogenemia); 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

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).