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Enzyme Immunoassay analyser - India CDSCO Medical Device Registration

Enzyme Immunoassay analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000022_14d39745478ff6bfbffa905e9b2f21cb_ff1138f5ca92821e8126aa39a333bdc6. 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
Enzyme Immunoassay analyser
UID: MFG/IVD/2023/000022_14d39745478ff6bfbffa905e9b2f21cb_ff1138f5ca92821e8126aa39a333bdc6

Brand Name

Semi automated

Device Class

Class A

Approving Authority

Tamil Nadu

Product Information

The Enzyme Immunoassay (Semi automated) analyser consists of holder for microplate 96 wells plates to record the absorbance/numerical values of microplates of various immunological assays like T3, T4, TSH, fT3, fT4, FSH, LH, Prolactin, progesterone, testosterone, HIV, HBsAg, HCV, Malaria, Dengue etc., which is part of ELISA 96 assay testing process

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