COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST - India CDSCO Medical Device Registration

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/2020/000021_122fa07bb4649114d1ab99191cfbf75b_9f3a05141fa9ee17cc320025c51a15d7. 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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CDSCO Registered

Class Class D

COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST

UID: MFG/IVD/2020/000021_122fa07bb4649114d1ab99191cfbf75b_9f3a05141fa9ee17cc320025c51a15d7

Brand Name

PathoCatchTM

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The CoviSelf™ COVID-19 Antigen Lateral Flow Test (PathoCatchTM) 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