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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Diagnosys Vision Limited
Authorized representative
🇮🇪 Ireland·1 Manufacturer·12 Devices
Diagnosys Vision Limited
Importer
🇮🇪 Ireland
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·May 16, 2018
Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 4, 2018
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·October 26, 2016
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 13, 2019