Xpert Xpress Cov-2 PLUS Test Kit CLIA Waived 10/Bx
This item can only be sold to licensed practitioner or any other person(s) or entity licensed by the State.
This item is a professional use item. If your State License number is on file, we can ship this item to you. Otherwise, please include your State License number in the comments section of the order.
This product has an Emergency Use Authorization (EUA) from the FDA. See attached documents: Emergency Use Authorization Letter, Instruction for Use, Healthcare Provider and Patient Fact Sheets.
This item is restricted. Please reach out to your Sales Consultant for your initial purchase.
This item requires a CLIA License to purchase this product.
This item is non-returnable.
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 product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.
Description
- • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
- • This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- • 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
Download Documents
Specifications
Item
Test Kit
Item Type
Cov-2 PLUS
Brand
Xpert Xpress
CLIA Classification
CLIA Waived