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Sources: EU EUDAMED, US FDA
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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.
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·September 18, 2019
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 3, 2018
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·August 30, 2023
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
RX Series Copper (Cu) Assay Ref. Number CU2340
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·February 14, 2024
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
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·July 31, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
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
IgE Calibrator Series
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·October 12, 2016
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
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·August 8, 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
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·March 27, 2019
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·February 27, 2019
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·April 17, 2019