Description
2439_QuickVue_FactSheet_r1
EUA-QuickVue-OTC-letter
QuickVue OTC HCP PI
Quickvue OTC User Instructions
Unit: 1 Box
Regulatory Status: EUA Approved Only
Test Time: Approx 10 Minutes
Storage Requirements: Room Temperature
Contents: Swabs – (2)individually wrapped sterile foam swabs, (2) Test Strips, (2) Pre-filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals
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.
The test is authorized for home use with self-collected anterior nasal (nares) swab samples in individuals aged 2 and older. This test is also authorized for home use for individuals aged 2 through 14 with an adult performing the test. The test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests.
The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19whentested twice over two or three days with at least 24 hours and no more than 36 hours between tests. This 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.
Individuals should provide all results obtained with this product to their healthcare provider for public health
reporting. All healthcare providers will report all test results they receive from individuals who use the QuickVue At-Home OTC COVID-19 Test Kit Page 2 of 15 authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The QuickVue At-Home OTC COVID-19 Test is authorizedfor non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
