Home › Device types › DDG
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
N Antiserum to Human Transferrin — Siemens Healthcare Diagnostics Products GmbHTinaquant Transferrin ver2 — Roche Diagnostics GmbHN Latex sTfR — Siemens Healthcare Diagnostics Products GmbHAccuDiag™ — Diagnostic Automation, Inc.IMMAGE — Beckman Coulter, Inc.Optilite Transferrin Kit — THE BINDING SITE GROUP LIMITEDN Supplementary Reagent L — Siemens Healthcare Diagnostics Products GmbHK-ASSAY® Transferrin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCsTfR Control Set — Roche Diagnostics GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.N Antiserum to Human Transferrin — Siemens Healthcare Diagnostics Products GmbHsTfR AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.ARCHITECT — ABBOTT IRELANDIMMAGE — Beckman Coulter, Inc.Tina-quant Transferrin ver. 2 — Roche Diagnostics GmbHK-ASSAY® Transferrin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCARCHITECT — ABBOTT LABORATORIESDImension Vista® Transferrin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHsTfR AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Access sTfR — Beckman Coulter, Inc.Alinity — Abbott GmbHTinaquant Transferrin ver2 — Roche Diagnostics GmbHsTfR AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Tinaquant Soluble Transferrin Receptor — 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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