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#1001197495 | Mfg #20402 | Clinical Laboratory

Rapid Test Kit QuickVue® At-Home OTC COVID-19 Test Nasal Swab Sample 2 Tests

TEST KIT, COVID-19 QUICKVUE AT-HOME OTC (2/BX 45BX/CS)
Rapid Test Kit QuickVue® At-Home OTC COVID-19 Test Nasal Swab Sample 2 Tests

For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

Product Specifications

MSFH #
1001197495
Manufacturer #
QuickVue®, 20402, Quidel
Brand
Individually Packaged, Individually Wrapped Sterile Foam Swabs, Rapid Test Kit, United States, (2) Single-Use Test Strips
Manufacturer
Pre-Filled Tubes
Country of Origin
Tube Holder
Application
Instruction Sheet
Contents 1
Fact Sheet for Individuals
HCPCS
U0004
Number of Tests
2 Tests
Product Dating
MSFH Acceptable Dating: we will ship >= 30 days
Reading Type
Visual Read
Sample Type
Nasal Swab Sample
Test Format
Test Strip Format
Test Method
Lateral Flow Immunoassay
Test Name
At-Home OTC COVID-19 Test
Time to Results
10 Minute Results
UNSPSC Code
41116205

Description

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

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