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Transferrin, Antigen, Antiserum, Control
FDA product code DDG · Class 2 · Immunology
43
Registered devices
2
Adverse events
6
Recalls
48
510(k) clearances
Devices with this code
Transferrin ver 2 Tinaquant Transferrin ver2 — Roche Diagnostics GmbHYumizen C1200 Transferrin — HORIBA ABX SASARCHITECT — ABBOTT LABORATORIESARCHITECT — Abbott GmbHIMMAGE — Beckman Coulter, Inc.Access sTfR — Beckman Coulter, Inc.sTfR AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.AccuDiag™ — Diagnostic Automation, Inc.Alinity — Abbott GmbHK-ASSAY® Transferrin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCK-ASSAY® Transferrin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCOptilite Transferrin Kit — THE BINDING SITE GROUP LIMITEDIMMAGE — Beckman Coulter, Inc.Tinaquant Soluble Transferrin Receptor — Roche Diagnostics GmbHARCHITECT — Abbott GmbHTF — RANDOX LABORATORIES LIMITEDN Latex sTfR — Siemens Healthcare Diagnostics Products GmbHTinaquant Transferrin ver2 — Roche Diagnostics GmbHTinaquant Soluble Transferrin Receptor — Roche Diagnostics GmbHTF — RANDOX LABORATORIES LIMITEDARCHITECT — ABBOTT IRELANDsTfR AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.N Supplementary Reagent L — Siemens Healthcare Diagnostics Products GmbHTina-quant Transferrin ver. 2 — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-09 | Randox Laboratories Ltd. | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertai |
| 2022-06-09 | Randox Laboratories Ltd. | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertai |
| 2019-08-28 | Roche Diagnostics Operations, Inc. | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| 2019-08-28 | Roche Diagnostics Operations, Inc. | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the variou |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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