FDA-Device2024-09-25Class II
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Cypress Medical Products LLC
Hazard
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Sold states
US Nationwide distribution.
Affected count
15 kits
Manufactured in
9954 Mayland Dr, Richmond, VA, United States
Products
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3184-2024Don't want to check this manually?
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