Fully Automated Coagulation Analyzer - India CDSCO Medical Device Registration

Fully Automated Coagulation Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000516_ff7ffccfc66c678ad1da242cb1c668ae_7bf98b2886a6f10a047b64d0e65adc51. This device is marketed under the brand name STA Compact Max® 3. The license holder is Syndicate Diagnostics 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

UID: IMP/IVD/2022/000516_ff7ffccfc66c678ad1da242cb1c668ae_7bf98b2886a6f10a047b64d0e65adc51

Brand Name

STA Compact Max® 3

License Holder

Syndicate Diagnostics Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The STA Satellite 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