Product Specifications
| McKesson # | 1179103 |
|---|---|
| Manufacturer # | AZ-CTRL-CW |
| Brand | Assure Tech |
| Manufacturer | Premier Biotech |
| Country of Origin | Unknown |
| Application | Control Set |
| Container Type | Vial |
| For Use With | For use with Assure COVID-19 IgG / IgM Assay |
| Form | Powder |
| Levels | Positive Level / Negative Level |
| Test Category | Respiratory |
| Test Name | COVID-19 IgG / IgM |
| Test Type | Antibody Test |
| UNSPSC Code | 41116128 |
Features
- The Assure COVID-19 IgG/IgM Rapid Test Device is for use under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests; this test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Assure COVID-19 IgG/IgM Control is intended to be used as external quality control material for the Assure COVID-19 IgG/IgM Rapid Test Device; the control can be used to verify proper performance of COVID-19 IgG/IgM Rapid Test kit
- The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection - at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes
- Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
- Negative controls are lyophilized human serum samples and positive controls are lyophilized IgG and IgM against SARS-CoV-2
- 2 Vials Neg / 1 Vial Pos allow for total 5 positive QC tests and 5 negative QC tests
More Information
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.
- Choosing a selection results in a full page refresh.