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Blood coagulation analyser - India CDSCO Medical Device Registration

Blood coagulation analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000022_f6ce2aa318601f3a6e29c6964ef23a72_d6edeb710732f87250f202ee287f7fbd. This device is marketed under the brand name Semi automated. The license holder is Genuine Biosystem Private Limited, and it is classified as Device Class Class A. The approving authority is Tamil Nadu.

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CDSCO Registered
Class Class A
Blood coagulation analyser
UID: MFG/IVD/2023/000022_f6ce2aa318601f3a6e29c6964ef23a72_d6edeb710732f87250f202ee287f7fbd

Brand Name

Semi automated

Device Class

Class A

Approving Authority

Tamil Nadu

Product Information

An analyzer intended to be used for the qualitative and/or of quantitative in vitro determination of one or multiple coagulation components involved in haemostasis like Prothrombin Time, partial thromboplastin, TT, Fibrinogen, protein-C, Protein-S, Factors etc., in a human clinical specimen of Plasma collected from Sodium citrate

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