FDA-Device2019-01-02Class II
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Randox Laboratories Ltd.
Hazard
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Sold states
US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
Affected count
250 kits (32 kits US / 218 kits OUS)
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0660-2019Don't want to check this manually?
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