Device product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Z-1017-2025
Product summary
- Event
- Event 96043
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-1017-2025
Official wording
Reason: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Code information: UDI-DI: 05055273204421 All lots within expiry
Distribution pattern: US Nationwide distribution Including PR.
Derived failure modes
-
Unknown
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.