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ENA Screen (MAGLUMI ENA Screen ) - India CDSCO Medical Device Registration

ENA Screen (MAGLUMI ENA Screen ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000151_d8940d1ae81e39f925948eaa82f271c8_4177d62899334cc65ab34ab2a7796bdf. This device is marketed under the brand name CLIA. The license holder is Medispace Solutions, 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
ENA Screen (MAGLUMI ENA Screen )
UID: IMP/IVD/2022/000151_d8940d1ae81e39f925948eaa82f271c8_4177d62899334cc65ab34ab2a7796bdf

Brand Name

CLIA

License Holder

Medispace Solutions

Device Class

Class B

Approving Authority

CDSCO

Product Information

The kit is an in vitro chemiluminescence immunoassay for the semi-quantitative determination of IgG class antibodies to extractable nuclear antigens (CLIA) in human serum and plasma

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