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ANA Screen - India CDSCO Medical Device Registration

ANA Screen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000022_c09a203e1534684d2cc369e0de3d2d51_ff33625331785a7cdb197f60dfdd28d2. This device is marketed under the brand name Merilisa. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Gujarat.

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
ANA Screen
UID: MFG/MD/2018/000022_c09a203e1534684d2cc369e0de3d2d51_ff33625331785a7cdb197f60dfdd28d2

Brand Name

Merilisa

Device Class

Class B

Approving Authority

Gujarat

Product Information

ANA Screen kit is an indirect solid phase enzyme immunometric assay (Merilisa) designed for semiquantitative measurement of IgG antibodies directed against Sm (Merilisa), RNP/Sm, Scl-70, SS-A (Merilisa) (Merilisa), SS-B (Merilisa), Jo1, U1-SmRNP, CENP-B, dsDNA, and Histones in human serum or plasma. ANA Screen kit is intended for laboratory use only

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