| SKU # | 1190065 |
| Manufacturer # | 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) |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| Number of Tests | 2 Tests |
| On_Allocation | N |
| 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 |
| Supplier_ID | 487993 |
| Test Format | Test Strip Format |
| Test Kit Type | Rapid |
| 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
Returns Policy
You may return most new, unopened items within 30 days of delivery for a full refund. We'll also pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.).
You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).
If you need to return an item, simply login to your account, view the order using the 'Complete Orders' link under the My Account menu and click the Return Item(s) button. We'll notify you via e-mail of your refund once we've received and processed the returned item.
Shipping
We can ship to virtually any address in the world. Note that there are restrictions on some products, and some products cannot be shipped to international destinations.
When you place an order, we will estimate shipping and delivery dates for you based on the availability of your items and the shipping options you choose. Depending on the shipping provider you choose, shipping date estimates may appear on the shipping quotes page.
Please also note that the shipping rates for many items we sell are weight-based. The weight of any such item can be found on its detail page. To reflect the policies of the shipping companies we use, all weights will be rounded up to the next full pound.