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Fluorescent Immunoassay analyzer - India CDSCO Medical Device Registration

Fluorescent Immunoassay analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000022_d5903b802f78c63f9b2a4241ffe707f3_5cb4cb901ed225e5e9283efbe4c8d957. This device is marketed under the brand name Semi automated. The license holder is Genuine Biosystem Private Limited, and it is classified as Device Class Class A. The approving authority is Tamil Nadu.

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 A
Fluorescent Immunoassay analyzer
UID: MFG/IVD/2023/000022_d5903b802f78c63f9b2a4241ffe707f3_5cb4cb901ed225e5e9283efbe4c8d957

Brand Name

Semi automated

Device Class

Class A

Approving Authority

Tamil Nadu

Product Information

An analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or of various biological markers like ASO, CRP. RF, microalbuminurea, hSCRP, IgE, D-Dimer, Ferritin, T3, T4, TSH, fT3, fT4, FSH, LH, Prolactin, Progesterone, Testosterone, etc., in a human specimen like whole blood, serum, plasma, urine or body fluids by Fluorescent Immunoassay method (Semi automated)

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