Xpert Xpress Cov-2 PLUS Test Kit CLIA Waived 10/Bx
1421966 Cepheid - XP3SARS-COV2-10
Quantity
BX
Quantity
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.
Description
Xpert Xpress Cov-2 PLUS Test Kit CLIA Waived 10/Box
UOM
Product Overview/Technical Specification: Features & Benefits:
- • 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.
Catalog Description: <i>Artist: Please move the following copy to the beginning of the Note field, directly below the last item code, and remove the italics. Copy won't fit into field in Stibo:</i><br><i>This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. “Authorized Laboratories” means (i) for testing of nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, oropharyngeal swab or nasal wash/aspirate specimens using the Test Kits run on the GeneXpert Dx and GeneXpert Infinity systems, laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform high or moderate complexity tests; and (ii) for testing of nasopharyngeal swab, anterior nasal swab or mid-turbinate nasal swab specimens using the Xpert Xpress CoV-2 plus test run on the GeneXpert Xpress System (Tablet and Hub Configurations), laboratories certified under CLIA t
Product Attributes
Category
Molecular Testing
UNSPSC Taxonomy
41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS
Additional Attributes
Return Policy
Download Documents
105EC55_US_MSDS_01.pdf
PDF
Specifications
Item
Test Kit
Item Type
Cov-2 PLUS
Brand
Xpert Xpress
CLIA Classification
CLIA Waived