FDA-Device2024-09-25Class II

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

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
5 kits
Manufactured in
9954 Mayland Dr, Richmond, VA, United States
Products
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3185-2024

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