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Bilirubin Direct 4+1 - India CDSCO Medical Device Registration

Bilirubin Direct 4+1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000241_a99b91963dfbd4703ed826cfd6ac5678_1c4212eec5a05536612bbbe7b1341049. This device is marketed under the brand name Elitech Clinical Systems SAS. The license holder is Q-Line Biotech Private Limited (Formerly Known As POCT SERVICES PRIVATE LIMITED), and it is classified as Device Class Class B. 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.

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CDSCO Registered
Class Class B
Bilirubin Direct 4+1
UID: IMP/IVD/2022/000241_a99b91963dfbd4703ed826cfd6ac5678_1c4212eec5a05536612bbbe7b1341049

Brand Name

Elitech Clinical Systems SAS

Device Class

Class B

Approving Authority

CDSCO

Product Information

Elitech Clinical Systems BILIRUBIN DIRECT 4+1 SL is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma

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