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

Fully Automated Coagulation Analyzer(STA R Max ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000469_22d3cef7873b2d04493dcc0b32912455_8f87c30a5d206a838d0ae1cbb2c3d712. This device is marketed under the brand name STA Compact Max® 3 with cap-piercing and Coag Expert. The license holder is NISHA SALES, 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 R Max )

UID: IMP/IVD/2022/000469_22d3cef7873b2d04493dcc0b32912455_8f87c30a5d206a838d0ae1cbb2c3d712

Brand Name

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

License Holder

NISHA SALES

Device Class

Class A

Approving Authority

CDSCO

Product Information

The STA R 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