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Fully Automated Chemiluminescense Immunoassay analyser - India CDSCO Medical Device Registration

Fully Automated Chemiluminescense Immunoassay analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000088_2865595fcf88304980df263f8554da87_55dea404dea4d351490d4f6f3cc82c19. This device is marketed under the brand name YHLO. The license holder is M/s. 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
Fully Automated Chemiluminescense Immunoassay analyser
UID: IMP/IVD/2022/000088_2865595fcf88304980df263f8554da87_55dea404dea4d351490d4f6f3cc82c19

Brand Name

YHLO

Device Class

Class A

Approving Authority

CDSCO

Product Information

The iFlash chemiluminescence immunoassay analyzer is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human serum, plasma, or urine samples taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents including the following test items: vitamins, hormones, myocardial diseases, infectious diseases, autoantibodies, tumor-associated antigens, proteins, polypeptides, liver diseases, and immunity.

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