7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
×
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
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
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
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 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