FDA-Device2019-10-02Class III
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Randox Laboratories Ltd.
Hazard
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Sold states
US Nationwide distribution including the states of IN, WV.
Affected count
1 kit
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2019Don't want to check this manually?
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