Combur 10 Test UX - India CDSCO Medical Device Registration

Combur 10 Test UX is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_ff7155fa896b1150eb700af11cfaaf6a_4ace46a9d7326029871b1cedadbea8ef. This device is marketed under the brand name Antithrombin. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Combur 10 Test UX

UID: IMP/IVD/2018/000038_ff7155fa896b1150eb700af11cfaaf6a_4ace46a9d7326029871b1cedadbea8ef

Brand Name

Antithrombin

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Combur10 Test UX are test strips for the in vitro qualitative or semi quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, erythrocytes and specific gravity in urine with the Urisys 1100 urine analyzer and by visual reading. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. Combur10 Test UX are test strips for single use only. Combur10 Test UX are screening tests and can aid in the diagnosis of pathological conditions. Not for self-testing. The test is intended for near patient testing