5 results
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Beckman Coulter Ireland Inc.
Authorized representative
🇮🇪 Ireland·3 Manufacturers·1177 Devices
Biotech Europe Meditech Inc Limited
Authorized representative
🇮🇪 Ireland·1 Manufacturer·5 Devices
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Ireland, Inc.·December 31, 2025
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Ireland, Inc.·January 28, 2026
Apo B Reagent, REF: OSR6143
FDA Enforcement
Class III
·Ongoing·Beckman Coulter Ireland, Inc.·June 4, 2025