Description
- 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 Specs
| Item Number | 1276842 |
|---|---|
| Catalog Number | 20451 |
| UOM | CS |
| Level 1 Family Description | Lab-Waived Lab |
| Level 2 Category Description | Lab-Respiratory Testing |
| Level 3 Group Description | COVID Testing |
| Level 4 Sub-Category Description | Covid - OTC |
| Application | Respiratory Test Kit |
| Brand | QuickVue |
| 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 |
| Country of Origin | United States |
| HCPCS | K1034 |
| Manufacturer | Quidel |
| Manufacturer # | 20451 |
| McKesson # | 1277164 |
| Number of Tests | 2 Tests |
| 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 |