Transferrin, Antigen, Antiserum, Control
FDA product code DDG · Class II (moderate risk) · 21 CFR 866.5880 · Immunology
48510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Dade Behring, Inc. 5
- Beckman Instruments, Inc. 4
- Roche Diagnostics Corp. 3
- Boehringer Mannheim Corp. 3
- The Binding Site, Ltd. 2
- Beckman Coulter Inc. 2
- Abbott Laboratories 2
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Crestat Diagnostics, Inc. 1
- Instrumentation Laboratory CO 1
- Atlantic Antibodies 1
- Orion Diagnostica, Inc. 1
- Unipath , Ltd. 1
- Kallestad Laboratories, Inc. 1
- Cooper Biomedical, Inc. 1
- Applications Lab 1
- Biocell Laboratories, Inc. 1
- New England Immunology Assoc. 1
- Biosystems S.A. 1
- Kent Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240987 | Access sTfRDDG · Traditional | Beckman Coulter, Inc. | 07/03/2024SE |
| K190495 | TransferrinDDG · Traditional | Biosystems S.A. | 03/16/2020SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | Roche Diagnostics Operations (Rdo) | 11/05/2018SE |
| K120236 | Transferrin Kit for Use on the SpaplusDDG · Traditional | The Binding Site Group , Ltd. | 02/13/2013SE |
| K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…DDG · Traditional | Beckman Coulter, Inc. | 08/11/2008SE |
| K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…DDG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/08/2008SE |
| K063086 | Transferrin, Specical Calibrator, Specitrol and Specitrol High ControlsDDG · Traditional | Thermo Electron OY | 08/08/2007SE |
| K063766 | Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#…DDG · Traditional | Good Biotech Corp. | 04/23/2007SE |
| K063663 | Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…DDG · Traditional | Dade Behring, Inc. | 03/21/2007SE |
| K063322 | Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…DDG · Traditional | Dade Behring, Inc. | 01/24/2007SE |
| K053075 | N Antisera to Human TransferrinDDG · Traditional | Dade Behring, Inc. | 03/16/2006SE |
| K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…DDG · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/19/2004SE |
| K012393 | Tina-Quant Transferrin VER.2DDG · Traditional | Roche Diagnostics Corp. | 09/19/2001SE |
| K012371 | Tina-Quant Transferrin VER.2DDG · Traditional | Roche Diagnostics Corp. | 09/19/2001SE |
| K011662 | Minineph A-1 Transferrin Antiserum, High and Low Serum ControlDDG · Traditional | The Binding Site, Ltd. | 07/30/2001SE |
| K003064 | Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra…DDG · Traditional | Roche Diagnostics Corp. | 05/01/2001SE |
| K002585 | Randox TransferrinDDG · Traditional | Randox Laboratories, Ltd. | 02/05/2001SE |
| K994294 | Dimension TRNF Flex Reagent CartridgeDDG · Traditional | Dade Behring, Inc. | 02/04/2000SE |
| K993537 | K-Assay TransferrinDDG · Traditional | Kamiya Biomedical Co. | 11/30/1999SE |
| K993162 | Wako Transferrin, Transferrin CalibratorDDG · Traditional | Wako Chemicals USA, Inc. | 11/12/1999SE |
| K991157 | N Latex STFR ReagentDDG · Traditional | Dade Behring, Inc. | 08/02/1999SE |
| K983880 | Transferrin SPQ III Antibody Reagent SetDDG · Traditional | DiaSorin, Inc. | 12/18/1998SE |
| K983167 | TRFDDG · Traditional | Abbott Laboratories | 11/04/1998SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | Behring Diagnostics, Inc. | 10/17/1997SE |
| K971958 | Synchron LX Systems Transferrin (TRFN) ReagentDDG · Traditional | Beckman Instruments, Inc. | 08/20/1997SE |
| K964295 | N-Assay Tia Transferrin Test KitDDG · Traditional | Crestat Diagnostics, Inc. | 06/16/1997SE |
| K963976 | Immunochemistry Sys Urine Transferrin ReagentDDG · Traditional | Beckman Instruments, Inc. | 03/19/1997SE |
| K963427 | Immage Immunochemistry System Transferrin (TRF) ReagentDDG · Traditional | Beckman Instruments, Inc. | 10/07/1996SE |
| K933589 | Boehringer Mannheim Tina-Quant Transferrin AssayDDG · Traditional | Boehringer Mannheim Corp. | 11/03/1993SE |
| K926272 | Beckman Transferrin KitDDG · Traditional | Beckman Instruments, Inc. | 10/07/1993SE |
| K914993 | Il Test(Tm) Transferrin (TRF)DDG · Traditional | Instrumentation Laboratory CO | 01/17/1992SE |
| K914390 | Transferrin Rid KitDDG · Traditional | The Binding Site, Ltd. | 12/09/1991SE |
| K900875 | Raichem(Tm) Spia(Tm) Transferrin ReagentDDG · Traditional | Reagents Applications, Inc. | 03/06/1990SE |
| K890563 | Spq(Tm) Antibody Reagent Set II for TRFDDG · Traditional | Atlantic Antibodies | 03/03/1989SE |
| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | Orion Diagnostica, Inc. | 10/19/1988SE |
| K873867 | TransferrinDDG · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K873789 | QM300 Transferrin Antibody PackDDG · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 10/07/1987SE |
| K871896 | Tina-Quant [A] TransferrinDDG · Traditional | Boehringer Mannheim Corp. | 06/15/1987SE |
| K871022 | Precimat(R) TransferrinDDG · Traditional | Boehringer Mannheim Corp. | 05/14/1987SE |
| K854416 | TDX Transferrin Diagnostic KitDDG · Traditional | Abbott Laboratories | 02/21/1986SE |
| K851287 | Radial Immunodiffusion Plates TransferrinDDG · Traditional | Cooper Biomedical, Inc. | 05/24/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | Applications Lab | 03/05/1985SE |
| K830911 | Radial Immunodiffusion PlatesDDG · Traditional | Biocell Laboratories, Inc. | 06/10/1983SE |
| K813288 | Neia Transferrin EnzymeimmunoassayDDG · Traditional | New England Immunology Assoc. | 12/17/1981SE |
| K812492 | Immunogl. Frct. of Rabbit Antiser.-TranDDG · Traditional | Dako Corp. | 09/23/1981SE |
| K811613 | 72 Determin. Size Radial Immunod. TestDDG · Traditional | Kent Laboratories, Inc. | 08/12/1981SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | J.T. Baker Chemical Co. | 07/08/1980SE |
| K772253 | Transferrin Nephelometric AssayDDG · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1423-2022 Class III | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVDA customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an… | Randox Laboratories Ltd. | 06/09/2022Terminated |
| Z-1422-2022 Class III | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVDA customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an… | Randox Laboratories Ltd. | 06/09/2022Terminated |
| Z-0109-2020 Class II | cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog…Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference | Roche Diagnostics Operations, Inc. | 08/28/2019Terminated |
| Z-0108-2020 Class II | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference…Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference | Roche Diagnostics Operations, Inc. | 08/28/2019Terminated |
| Z-1995-2019 Class II | Transferrin is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |
| Z-0009-2009 | Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | Roche Diagnostics Corp. | 06/11/2008Terminated |