A rapid test for the detection of COVID-19 antigens in nasal specimens. To place orders and set up an account, call 877‑722‑8910.
Carolina Liquid Chemistries is now offering the Waived, FDA Emergency Use Authorized, Over the Counter (OTC) Flowflex™ COVID-19 Antigen Home Test
Fact Sheet for Healthcare Providers
Emergency Use Authorization Letter from the FDA
EUA Letter Update from the FDA
FDA Guidance – Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency
FDA EUA Viral Mutation Revision
Description
- Easy and Affordable
- Highly Accurate Nasal Swab Test
- Quick Results in 15 minutes
- Safe for children as young as 2 years old
- For use with and without symptoms
Kit includes
- 1 Test Cassette
- 1 Extraction Buffer Tube
- 1 Disposable Nasal Swab
- 1 Package insert (instructions for use)
Important Information
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.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs 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. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Flowflex is a trademark of ACON Laboratories, Inc.
Other COVID-19 Related Products
Fastep® COVID-19 Antigen Home Test (FDA EUA Granted)
Clarity COVID-19 Antigen Rapid Test Cassette (FDA EUA Granted)
Sienna™ COVID-19 Antigen Rapid Test Cassette (FDA EUA Granted)
POC/Waived/Fingerstick Fastep® COVID-19 IgG/IgM Rapid Test Device by Azure Biotech (FDA EUA Granted)
Status™ COVID-19/Flu A&B Antigen Test (FDA EUA Granted)
