NDC:
14613033972
Product shelf life minimum: Jan 2025
FDA Extension Link
Quidel Corporation: QuickVue At-Home OTC COVID-19 Test self-life extension (fda.gov)
Description:
1 Pack, 2 Tests Total, Self-Collected Nasal Swab Sample, 10 Minute Rapid Results
The QuickVue At-Home OTC COVID-19 Test is designed for both symptomatic and asymptomatic individuals. It aims to qualitatively detect the nucleocapsid proteins from SARS-CoV-2, whether or not there are symptoms or other reasons to suspect COVID-19. The test should be administered twice within a 24 to 36-hour timeframe. The kit includes pre-filled vials, eliminating the chance of errors in dosage. A positive result signals the presence of a viral agent, though further clinical correlation with the individual's medical history and other diagnostic data is required to confirm infection. The results may assist in preventing the spread of COVID-19 within your family and community. In clinical trials, this test successfully identified positive cases 83.5% of the time and negative cases 99.2% of the time.
Product Features & Details:
- Get rapid COVID-19 test results in just 10 minutes with this easy-to-use at-home testing kit.
- The non-invasive design allows for gentle swabbing of your nose, placing it in a pre-filled tube, and quickly obtaining results.
- FDA Emergency Use Authorized and FSA/HSA eligible, ensuring safety and affordability.
- Designed for individuals aged 14 or older for self-collected nasal swabs; children aged 2+ can be tested if an adult collects the sample.
- Results are straightforward, indicated by a pink or blue line on the test strip. - Suitable for individuals with or without symptoms, providing convenient at-home COVID-19 screening.
- Each kit contains 2 sterile foam swabs for testing twice over 3 days, pre-filled tubes for easy testing, a tube holder, instruction sheet, and patient fact sheets.
- Please note that this test kit does not provide the necessary documentation for specific purposes such as air travel or testing programs.
Check the requirements for your specific testing needs.
How to use:
1. Collect a gentle nasal swab sample.
2. Add the swab to the solution tube and swirl.
3. Dip the strip into the tube.
4. Read the straightforward and easy-to-read results.
