Respiratory Test Kit QuickVue® COVID-19 Test 2 Tests CLIA Waived KT/CS MK-1277164
$24.95
Features
- QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under the new name – QuickVue COVID-19 Test
- The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset
- This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older
- The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2
- All negative results are presumptive
- Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment
- Positive results do not rule out co-infection with other respiratory pathogens
Product Specifications
| McKesson # | 1277164 |
|---|---|
| Manufacturer # | 20451 |
| Brand | QuickVue® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| Buy American Act (BAA) Compliant | Yes |
| CLIA Classification | CLIA Waived |
| CLIA Classified | CLIA Waived |
| Contents 1 | (2) COVID-19 Test Strips, (2) Pre-Filled Reagent Tubes, (2) Strip Replacement Cards, (2) Swabs, User Instructions |
| HCPCS | K1034 |
| Number of Tests | 2 Tests |
| 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 |
| Test Format | Test Strip Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow |
| Test Name | COVID-19 Test |
| Test Type | Home Test Device |
| Time to Results | 10 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116144 |
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FDA Disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."