Device product
Gonorrhea test
Z-0738-2026
Product summary
- Event
- Event 97896
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 463 units
- Official record key
device-enforcement:Z-0738-2026
Official wording
Reason: Distribution without premarket approval/clearance.
Code information: EAN: 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Distribution without premarket approval/clearance.