ECL-100 Fully Automated Chemiluminescence Analyzer
- UID
- IMP/IVD/2023/000474_f493d4ae580def98991cc04ce44b39c4_bf295412cedd00558e3d1b87709cbd2f
- Device class
- Class A
- Brand name
- Epitope
- License holder
- Immunoconcept India Private Limited
- 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."
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.
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.