Point-of-Care Antigen Test for SARS-CoV-2. To place orders and set up an account, call 877-722-8910.
Sienna™ COVID-19 Antigen Rapid Test Cassette
Carolina Liquid Chemistries is now offering the Point-of-Care (POC)/Waived, FDA Emergency Use Authorized Sienna™ COVID-19 Antigen Rapid Test
Instructions for Use (includes Quick User Guide)
Fact Sheet for Healthcare Providers
Emergency Use Authorization Letter from the FDA
FDA Guidance – Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency
FDA EUA Viral Mutation Revision
Kit includes
- 25 Individually pouched test cassettes
- 25 Sterile naso-pharyngeal swabs
- 25 Buffer tubes
- 1 Negative control swab
- 1 Positive control swab
- 1 Workstation
- 1 Package insert (instructions for use)
- 1 Quick start guide
Due to supply chain demands, all orders for this product are non-cancellable and non-returnable.
Important Information
The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Other COVID-19 Related Products
Flowflex™ COVID-19 Antigen Home Test (FDAĀ EUAĀ Granted)
Clarity COVID-19 Antigen Rapid Test Cassette (FDAĀ EUAĀ Granted)
Sienna™ COVID-19 Antigen Rapid Test Cassette (FDAĀ EUAĀ Granted)
Status™ COVID-19/Flu A&B Antigen Test (FDAĀ EUAĀ Granted)
QuantiVirus™ SARS-CoV-2 Test Kit from DiaCarta (FDAĀ EUAĀ Granted)
QuantiVirus™ SARS-CoV-2 Multiplex Test Kit from DiaCarta (FDAĀ EUAĀ Granted)
Nucleic Acid Extraction Instruments
Serology Quality Controls for Infectious Diseases (3rd Party QC)