COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST
- UID
- MFG/IVD/2021/000070_122fa07bb4649114d1ab99191cfbf75b_9f031b1f15b63a22614d818591ff871b
- Device class
- Class D
- Brand name
- PathoCatch
- License holder
- M/s Mylab Discovery Solutions Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- The CoviSelf™ COVID-19 Antigen Lateral Flow Test (PathoCatch) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens directly from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. This test is authorized for nonprescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult-collected nasal swab samples from individuals aged 2 years or older.
COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000070_122fa07bb4649114d1ab99191cfbf75b_9f031b1f15b63a22614d818591ff871b. This device is marketed under the brand name PathoCatch. The license holder is M/s Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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.