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Quidel 20402 Rapid Test Kit QuickVue® At-Home OTC COVID-19; Test Direct Anterior Nasal (NS) Swab Sample 2 Tests. Box with 02 tests

$35.00

Quidel 20402 Rapid Test Kit QuickVue® At-Home OTC COVID-19; Test Direct Anterior Nasal (NS) Swab Sample 2 Tests. Box with 02 tests

$35.00
SKU:
20402
Weight:
2.00 LBS
Shipping:
Calculated at checkout
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Product Description

Quidel 20402 Rapid Test Kit QuickVue® At-Home OTC COVID-19; Test Direct Anterior Nasal (NS) Swab Sample 2 Tests. Box with 02 tests

Features

  • 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

  • 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

Manufacturer  # 20402
Brand QuickVue®
Manufacturer Quidel
Country of Origin Unknown
Application Rapid Test Kit
Contents Individually Wrapped Sterile Foam Swabs, Individually Packaged, (2) Single-Use Test Strips, Pre-Filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals
HCPCS U0004
Number of Tests 2 Tests
Reading Type Visual Read
Sample Type Direct Anterior Nasal (NS) 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

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