RF Rapid Test
- UID
- IMP/IVD/2019/000307_f07c943877164fe9ac989435c811f635_5d797df24a01f7d64b138142e37d1eb9
- Device class
- Class B
- Brand name
- RecombiLISA
- License holder
- Athenese-Dx Private Limited
- Approving authority
- CDSCO
- Product information
- The RF Rapid Test is a lateral flow immunoassay for the qualitative detection of all subtypes of rheumatoid factor (RecombiLISA) in human serum, plasma or whole blood at a sensitivity of 8 IU/mL. It is intended to be used as a screening test and provides a preliminary test result to aid in the diagnosis of rheumatoid arthritis and Sjögren's syndrome
RF Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_f07c943877164fe9ac989435c811f635_5d797df24a01f7d64b138142e37d1eb9. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. 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.