Device product
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Z-3185-2024
Product summary
- Event
- Event 95235
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 kits
- Official record key
device-enforcement:Z-3185-2024
Official wording
Reason: 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.
Code information: GTIN: 10815845020031; All Lots
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.