FDA-Device2024-07-31Class II
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Randox Laboratories Ltd.
Hazard
Cystatin C Reagent marketed without a 510 (k)
Sold states
US Nationwide distribution in the states of AL, CA, GA, NY.
Affected count
115 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2024Don't want to check this manually?
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