Flowflex Home Test COVID-19 Antigen OTC 10/Bx
1414132 Acon Laboratories, Inc - L031-118B5
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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.
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 is a non-returnable item.
This item is non-returnable.
Description
Flowflex Home Test COVID-19 Antigen OTC 10/Box • This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for non-prescription use. • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, • 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[1]3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
BX
Product Attributes
Category
Respiratory
UNSPSC Taxonomy
41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS
Additional Attributes
Return Policy
Download Documents
105DS68_US_MSDS_01.pdf
PDF
IFU0046_US_Letter_01.pdf
PDF
Specifications
Item
COVID-19 Antigen
Item Type
Home Test
Brand
Flowflex
Secondary Size
Single Test
CLIA Classification
OTC