COVID19 Antigen Rapid Test Kit (20tests/bx)

• Detects SARS-CoV-2 Nucleocapsid Antigen from Nasal Swab
• Delivers Qualitative Results in 15 Minutes
• Features CLIA-Waived & 510(k) Cleared Performance
• Includes 20 Complete Tests w/ Positive and Negative Controls
• Utilizes Instrument-Free Lateral Flow Technology
• Made in the USA for Professional Point-of-Care Testing .

The Clarity Diagnostics COVID19 Antigen Rapid Test Kit is a rapid lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in directly collected anterior nasal swab specimens. The assay is intended for professional use as an aid in the diagnosis of COVID-19 in symptomatic individuals, and is authorized for testing symptomatic individuals within the first 4 days of symptom onset. instrumentation.

✔ 510(k) CLEARED | ✔ CLIA WAIVED | ✔ RESULTS IN 15 MINUTES

RELIABLE SARS-CoV-2 DETECTION

QUALITATIVE ANTIGEN ASSAY: Detects SARS-CoV-2 nucleocapsid antigen from directly collected anterior nasal swab specimens to assist healthcare professionals in the evaluation of patients with suspected COVID-19.

FAST VISUAL RESULTS: Test and control lines provide qualitative results in approximately 15 minutes without the need for an analyzer or reader.

REGULATORY STATUS: The assay is 510(k) Cleared, CLIA Waived, and authorized for use in eligible point-of-care settings operating under the appropriate CLIA certification.

COMPLETE TESTING SOLUTION

COMPLETE 20-TEST KIT: Each box contains 20 individually pouched test devices, 20 sample collection swabs, extraction buffer, reagent tubes, positive and negative control swabs, a package insert, and a quick reference guide.

READY-TO-USE FORMAT: Preconfigured testing components simplify specimen preparation and support efficient workflow with minimal equipment requirements.

QUALITY CONTROL: Internal procedural controls verify proper specimen migration during every test, while the supplied positive and negative control swabs support routine quality assurance.

The Clarity Diagnostics COVID-19 Antigen Rapid Test Kit combines rapid turnaround, straightforward operation, and regulatory-cleared performance in a complete testing package, providing healthcare professionals with a dependable solution for qualitative SARS-CoV-2 antigen detection in point-of-care environments.

**FDA Disclaimer: This test is not FDA cleared or approved, but only authorized under an Emergency Use Authorization for use by authorized laboratories. It is authorized for the rapid detection of proteins from SARS-CoV-2 and 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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

WARNING: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.