Fully Automated Coagulation Analyzer(STA Compact Max ) - India CDSCO Medical Device Registration

Fully Automated Coagulation Analyzer(STA Compact Max ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000179_d0fd264a13a18b1e4bff45a6a781b248_49a8633973d5a170a041f9f0b6331993. This device is marketed under the brand name STA Compact Max® 3 with cap-piercing and Coag Expert. The license holder is Lifesign Healthcare Pvt.Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Fully Automated Coagulation Analyzer(STA Compact Max )

UID: IMP/IVD/2023/000179_d0fd264a13a18b1e4bff45a6a781b248_49a8633973d5a170a041f9f0b6331993

Brand Name

STA Compact Max® 3 with cap-piercing and Coag Expert

License Holder

Lifesign Healthcare Pvt.Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The STA Compact Max® is a fully automatic clinical analyzer intended to be used by professional laboratory personnel for qualitative and/or quantitative in vitro determination and to perform clotting, chromogenic and immunoassay tests on human venous plasmas the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.