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/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.

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CDSCO Registered

Class Class D

COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST

UID: MFG/IVD/2021/000070_122fa07bb4649114d1ab99191cfbf75b_9f031b1f15b63a22614d818591ff871b

Brand Name

PathoCatch

License Holder

M/s Mylab Discovery Solutions 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 (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.