COVID-19 Real Time PCR Detection Kit
- UID
- MFG/IVD/2021/000136_715cff8e4f231d7ef48784c40f51d6db_12290f0c5697ff136ca3349fc987954f
- Device class
- Class C
- Brand name
- ErbaMDx COVID-19 RT-PCR Kit
- License holder
- Transasia Diagnostics Private Limited
- Approving authority
- CDSCO, Zonal office, Hyderabad
- Product information
- Erba MDx COVID-19 RT-PCR Kit is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in samples collected from patients with a clinical suspicion and/or signs and symptoms suggestive of COVID-19 infection. Results are for the detection of SARS-CoV-2 RNA in nasopharyngeal & oropharyngeal swab samples during suspected COVID-19 infection, as an aid to diagnosis.
COVID-19 Real Time PCR Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000136_715cff8e4f231d7ef48784c40f51d6db_12290f0c5697ff136ca3349fc987954f. This device is marketed under the brand name ErbaMDx COVID-19 RT-PCR Kit. The license holder is Transasia Diagnostics Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.
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.