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Hepatitis E virus Antibody Test - India CDSCO Medical Device Registration

Hepatitis E virus Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000103_93c514a0db1e08d3b6853f6cd998e046_89c10f8326a0451d496435a7749d7f18. This device is marketed under the brand name RF-IgM. The license holder is Genovik Biotech Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Rajasthan.

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
Hepatitis E virus Antibody Test
UID: MFG/IVD/2023/000103_93c514a0db1e08d3b6853f6cd998e046_89c10f8326a0451d496435a7749d7f18

Brand Name

RF-IgM

Device Class

Class B

Approving Authority

Rajasthan

Product Information

GENOVIK Hepatitis E virus (RF-IgM) Antibody Test is a rapid chromatographic immunoassay for the qualitative detection of antibody IgM to Hepatitis E virus (RF-IgM) in serum or plasma. The results are used with other tests and clinical findings

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