64 results
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Sources: EU EUDAMED, US FDA
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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
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·April 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·April 24, 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
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·August 16, 2023
Multichem P, Part Code 08P90-10
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.
FDA Enforcement
Class II
·Terminated·Merck Millipore Ltd.·November 28, 2018
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
FDA Enforcement
Class II
·Ongoing·Creganna Medical Devices·August 9, 2023
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
FDA Enforcement
Class III
·Ongoing·T.G. Eakin Limited·October 2, 2024
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·June 26, 2019
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·May 9, 2018
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
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
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·November 8, 2023
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
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·February 27, 2019
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
FDA Enforcement
Class II
·Ongoing·Mallinckrodt Pharmaceuticals Ireland Ltd·February 16, 2022