Status COVID-19 Antigen Diagnostic Test EUA 150/Ca
Price
This product has an Emergency Use Authorization (EUA) from the FDA. See attached documents: Emergency Use Authorization Letter, Instruction for Use, Healthcare Provider Fact Sheets, Patient Fact Sheets, and Quick Reference Instructions.
Please note: This item is currently under a restricted allocation for specific customers. The item(s) may be canceled from your order if the account is not authorized to purchase. Please refer to the Alternate Product options listed on the Product Details Page or contact your sales representative for additional information.
This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.
This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.
This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.
This product is no longer available. It is maintained in Aruba so that customers with purchase history can see the descriptions. Pleasesearch for a substitute.
This item is non-returnable.
This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.
This item is Restricted for Specific Customers
Description
- • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
- • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogen.
- • The emergency use of this product 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 declaration is terminated or authorization is revoked sooner.
Product Attributes
Return Policy
Specifications
Item
Diagnostic Test
Item Type
COVID-19 Antigen
Brand
Status
Packaging
Single
CLIA Classification
EUA