HAV IgG/IgM Rapid Test
- UID
- IMP/IVD/2019/000307_c9e9cea646184e2f01be3dcbb33480b2_09c30a825b996f6a2a8c4b813665e4a3
- Device class
- Class B
- Brand name
- RecombiLISA
- License holder
- Athenese-Dx Private Limited
- Approving authority
- CDSCO
- Product information
- The HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (RecombiLISA) to Hepatitis A virus (RecombiLISA) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals and provide a preliminary result to aid in the diagnosis of active and/or past HAV infection
HAV IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_c9e9cea646184e2f01be3dcbb33480b2_09c30a825b996f6a2a8c4b813665e4a3. 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.
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