8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
×
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
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 13, 2019
CRP (Latex) Control Serum
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Ireland Inc.·1 device
Mylan IRE Healthcare Limited
Importer
🇮🇪 Ireland
Schottlander (IRL) Ltd
Authorized representative
🇮🇪 Ireland·1 Manufacturer·1 Device
PAREXEL INTERNATIONAL (IRL) LIMITED
Authorized representative
🇮🇪 Ireland
Meridius Medical Europe Limited
Authorized representative
🇮🇪 Ireland·36 Manufacturers·720 Devices
CRITICAL HEALTHCARE LIMITED
Importer
🇮🇪 Ireland·69 Manufacturers