BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER
- UID
- MFG/IVD/2020/000021_e231a994356c6fbc4ae981c897a965e9_a315a14eacea0378c5ce6025fa5598af
- Device class
- Class D
- Brand name
- PathoCatchTM
- License holder
- Mylab Discovery S0lutions Pvt. Ltd
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- The BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER are intended to be used in COVID-19 Antigen Lateral Flow Test (PathoCatchTM) after its filling and packaging as per Company SOP; which 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 final test kit after its secondary packaging and filling will be 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
BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_e231a994356c6fbc4ae981c897a965e9_a315a14eacea0378c5ce6025fa5598af. This device is marketed under the brand name PathoCatchTM. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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