Device product
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Z-2425-2024
Product summary
- Event
- Event 94858
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 115 kits
- Official record key
device-enforcement:Z-2425-2024
Official wording
Reason: Cystatin C Reagent marketed without a 510 (k)
Code information: GTIN: 05055273208665 All lots
Distribution pattern: US Nationwide distribution in the states of AL, CA, GA, NY.
Derived failure modes
-
Unknown
Cystatin C Reagent marketed without a 510 (k)