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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 IMP/IVD/2023/000467_8f26480ec980e34cfd84e2a8cb76c911_d02ffccfb1732bab33c9d984c8d8f351. This device is marketed under the brand name B.R.A.H.M.S KRYPTOR Compact PLUS. The license holder is CPC DIAGNOSTICS PVT.LTD, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
Fluorescent Immunoassay Analyser
UID: IMP/IVD/2023/000467_8f26480ec980e34cfd84e2a8cb76c911_d02ffccfb1732bab33c9d984c8d8f351

Brand Name

B.R.A.H.M.S KRYPTOR Compact PLUS

Device Class

Class A

Approving Authority

CDSCO

Product Information

The BยทRยทAยทHยทMยทS KRYPTOR compact PLUS is a fully automated in vitro diagnostic device. It is used for the measurement of different laboratory parameters in human clinical specimen in combination with the respective BยทRยทAยทHยทMยทS KRYPTOR assays offered by BยทRยทAยทHยทMยทS GmbH. The system is based on TRACEโ„ข technology (B.R.A.H.M.S KRYPTOR Compact PLUS). The Intended Use of each laboratory parameter available for BยทRยทAยทHยทMยทS KRYPTOR compact PLUS is declared in the parameter-related Intended Use/ Intended Purpose Statement

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DJ Fang

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