Xpert Xpress Mpox Test 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.
STOP! First time purchases of this EUA item cannot be done via the internet. All attempts will be canceled. To place your initial order, reach out to your sales consultant or call 1-800-772-4346.
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 requires a CLIA License to purchase this product.
Description
- • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories.
- • This product has been authorized only for the detection of nucleic acid from monkeypox virus or other non-variola orthopoxviruses, 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 infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, 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.
- • Testing on the Gen
Product Attributes
Return Policy
Download Documents
Specifications
Item
Test
Item Type
Mpox
Brand
Xpert Xpress
Quantity
10/Box
Additional Attributes
EUA
CLIA Classification
CLIA Waived