FDA-Device2019-09-18Class III
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Randox Laboratories Ltd.
Hazard
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Sold states
Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Affected count
307 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2490-2019Don't want to check this manually?
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