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ECL-100 Fully Automated Chemiluminescence Analyzer - India CDSCO Medical Device Registration

ECL-100 Fully Automated Chemiluminescence Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000474_f493d4ae580def98991cc04ce44b39c4_bf295412cedd00558e3d1b87709cbd2f. This device is marketed under the brand name Epitope. The license holder is Immunoconcept India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
ECL-100 Fully Automated Chemiluminescence Analyzer
UID: IMP/IVD/2023/000474_f493d4ae580def98991cc04ce44b39c4_bf295412cedd00558e3d1b87709cbd2f

Brand Name

Epitope

Device Class

Class A

Approving Authority

CDSCO

Product Information

ECL100 is Fully Automated Chemiluminescence Analyzer and Europian The product is based on an acridine ester direct chemiluminescence method to perform qualitative or quantitative detection of analytes in human serum, plasma, whole blood, or fecal samples. For in vitro diagnostic use only."

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