418 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
×
Liquid Cardiac Control, CQ5052
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 14, 2018
Liquid Cardiac Control, CQ5051
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 14, 2018
Liquid Cardiac Control, CQ5053
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 14, 2018
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
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical Division·November 22, 2023
RANDOX Total Bilirubin.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·December 13, 2023
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·April 1, 2020
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 28, 2021
IgE Calibrator Series
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·October 12, 2016
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·February 12, 2020
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 24, 2024
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
Fructosamine Calibrator, FR2993 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
Fructosamine Control 3, FR2996 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
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
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 2, 2019
Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023