FDA-Device2024-04-03Class II
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Randox Laboratories Ltd.
Hazard
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Sold states
US Nationwide distribution in the states of CA, IN.
Affected count
666 units
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2024Don't want to check this manually?
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