34 results
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28ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
FDA Enforcement
Class II
·Ongoing·Randox Laboratories·April 5, 2023
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
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
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
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
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·November 8, 2023
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·November 8, 2023
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
RANDOX Total Bilirubin.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·December 13, 2023
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·September 27, 2023
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·November 8, 2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023