14 results
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20ms
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Sources: EU EUDAMED, US FDA
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
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
FDA Enforcement
Class III
·Terminated·Randox Laboratories·June 7, 2017
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
FDA Enforcement
Class III
·Terminated·Randox Laboratories·March 21, 2018
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA Enforcement
Class III
·Terminated·Randox Laboratories·March 21, 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
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
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·August 14, 2019
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 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
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 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
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·November 20, 2019
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·October 2, 2019
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·February 12, 2020
CK MB Calibrator, Catalogue Number CK2393
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·May 25, 2022