Reference Number: RCPM-00271
The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.
- 2 Test Devices
- 2 Extraction Vials and Caps
- 2 Nasal Swabs
- Quick Reference Instructions
- Fact Sheet for Individuals
Reference Number: RCPM-00271
The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.
- This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
- This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
- This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at orders@lochnessmedical.com or 1-888-506-2658.
Canada