Fully automated clinical chemistry analyser - India CDSCO Medical Device Registration

Fully automated clinical chemistry analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000015_48aa3fec75b8f161bf55e8ceed60e16b_1e2723c74dc5b279d5496a96adf6eff0. This device is marketed under the brand name QDx Urilyzer 100 pro. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class A. The approving authority is Kokan Division.

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CDSCO Registered

Class Class A

Fully automated clinical chemistry analyser

UID: MFG/IVD/2022/000015_48aa3fec75b8f161bf55e8ceed60e16b_1e2723c74dc5b279d5496a96adf6eff0

Brand Name

QDx Urilyzer 100 pro

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class A

Approving Authority

Kokan Division

Product Information

The product is a fully automated clinical chemistry analyzer for quantitative analysis of chemical components in human samples (QDx Urilyzer 100 pro), which can assist in the diagnosis of normal people and patients with related diseases. The product has no independent measuring function and uses the supporting biochemical reagent kit manufactured by DiaSys to finish testing. The detectable indicators include: liver function, renal function, ion-metabolization, blood sugar, blood fat, myocardium enzymogram, immunity and other items.