Semi-automated Blood Coagulation Analyzer CA-101 - India CDSCO Medical Device Registration
Semi-automated Blood Coagulation Analyzer CA-101 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000033_f2fa83c60a9365d769845cf057e17b22_533e6df09b5a4de559b7e660ca69f3bb. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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License Holder
Sysmex India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The CA-101 is a semi-automated coagulation analyzer for the measurement of clotting tests as an aid to diagnosis and monitoring. The specimen required is human citrate plasma. The analyzer is intended for in-vitro diagnostic use by trained laboratory and healthcare professionals only
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