Metrix COVID-19/Flu A&B Starter Bundle CLIA Waived Ea
Price
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.
Please note this item may ship standard ground delivery service. If you need priority delivery on this item, please remove the item from the cart and call 800-372-4346 to speak with a sales representative who can assist in having this item expedited from the manufacturer if possible.
This product is shipped directly from the manufacturer and may incur additional fees and/or freight charge from the manufacturer. Item is non-returnable.
This item is non-returnable.
This item is non-returnable.
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 and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens.
- • 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
Starter Bundle
Item Type
COVID-19/Flu A&B
Brand
Metrix
Quantity
Each
With
50 Tests and 1 reader
CLIA Classification
CLIA Waived