Quidel Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test Nasal Swab Sample 2 Tests - Box of 1 - 20402-BX
Quidel Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test Nasal Swab Sample 2 Tests - Box of 1 - 20402-BX
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Quidel Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test Nasal Swab Sample 2 Tests - Box o...
| Item Id | 1197495 |
| MF Id# | 20402 |
| Brand | QuickVue® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classified | CLIA Waived |
| Contents 1 | 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 (Disclaimer) |
| Number of Tests | 2 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| 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 |
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
- 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