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Fluorescent Immunoassay Analyser - India CDSCO Medical Device Registration

Fluorescent Immunoassay Analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000064_8f26480ec980e34cfd84e2a8cb76c911_c9d19648c7f52b212f15422e456a05db. This device is marketed under the brand name PCR. The license holder is Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is Pune Division.

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CDSCO Registered
Class Class A
Fluorescent Immunoassay Analyser
UID: MFG/IVD/2023/000064_8f26480ec980e34cfd84e2a8cb76c911_c9d19648c7f52b212f15422e456a05db

Brand Name

PCR

Device Class

Class A

Approving Authority

Pune Division

Product Information

The analyzer is used to scan a fluorescent immunoassay reagent vehicle after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in clinical specimen with the help of MylabCare software

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