Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test 25 Tests CLIA Waived

Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test 25 Tests CLIA Waived


:In stock

SKU # 1191855
Manufacturer # 20398
Brand QuickVue®
Manufacturer Quidel
Country of Origin United States
Application Respiratory Test Kit
CLIA Classified CLIA Waived
Contents 1 Individually Wrapped Sterile Foam Swabs, (25) Test Strips, Pre-filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals
Is_Active_Vendor Y
Is_Discontinued N
Is_Medical_Device N
Lot_Tracking_Flag N
Number of Tests 25 Tests
On_Allocation N
Product Dating McKesson Acceptable Dating: we will ship >= 60 days
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Nasal Swab Sample
Specialty Immunoassay
Supplier_ID 487993
Test Format Test Strip Format
Test Kit Type Rapid
Test Method Lateral Flow Immunoassay
Test Name At-Home OTC COVID-19 Test
Time to Results 10 Minute Results
UNSPSC Code 41116144


  • For Use Under an Emergency Use Authorization (EUA) Only:
  • Product ships with minimum 30 days dating
  • The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested 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
  • Positive results indicate the presence of virus-specific proteins, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
  • Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
  • Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
  • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
  • The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
  • In the event of resale: Strict adherence to the adherence to the Conditions Related to Printed Materials, Advertising and Promotion contained in the Emergency Use Authorization (EUA) is required; o Minimum Advertised Price of $24.95 must be used