QuickVue Rapid Antigen At-Home OTC COVID-19 Test, 25 test/kit
Description
- Product #
- 29TDP
- Brand / Manufacturer
- QUIDEL
- Manufacturer Model #
- 20398
QuickVue At-Home OTC COVID-19 Test lets you get rapid results, in the privacy of your own home. Available over-the-counter, everything you need is in the package and taking the test is simple.
This home test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. The test to be used in individuals within 6-days of symptom onset or individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
For purchase by end users only; not intended for further resale or distribution.
EUA: https://www.fda.gov/media/147247/download
Fact Sheet for Individuals: https://www.fda.gov/media/147249/download
Fact Sheet for Healthcare Professionals: https://www.fda.gov/media/147248/download
Healthcare Provider Instructions for Use: https://www.fda.gov/media/147265/download
Instructions for Use Home Testing: https://www.fda.gov/media/147250/download
Specifications
- Returnable
- No - Hygiene/Medical Product
- Contains Forever Chemicals
- No
- External Controls Included
- Yes
- Internal Controls Included
- Yes
- Time to Results
- 10 min
- Percent Positive Agreement With RT_PCR
- 83.5
- Percent Negative Agreement With RT_PCR
- 99.2
- Sample Type
- Direct Anterior Nasal Swab
- Storage Temperature
- 59 F-86 F
- CLIA Complexity
- Waived Tests
- CA Prop 65 Warning
- Does not apply
- For professional use only?
- No
- Prescription Required
- No