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Anti M2-3E ELISA - India CDSCO Medical Device Registration

Anti M2-3E ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349. This device is marketed under the brand name NIL. The license holder is M/s. CPC Diagnostics Pvt Ltd, 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
Anti M2-3E ELISA
UID: IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349

Brand Name

NIL

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ELISA test kit provides a semiquantitative or quantitative in vitro assay for human antibodies of the immunoglobulin class IgG against the mitochondrial antigens M2 in serum or plasma to support the diagnosis of primary biliary cirrhosis (NIL) and overlap syndrome with autoimmune hepatitis

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