FDA-Device2019-12-18Class II
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Opti
The Binding Site Group, Ltd.
Hazard
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Sold states
US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
Affected count
10 kits
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0671-2020Don't want to check this manually?
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