Ferritin, Antigen, Antiserum, Control
FDA product code DBF · Class II (moderate risk) · 21 CFR 866.5340 · Immunology
87510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Amersham Corp. 6
- Kamiya Biomedical Co. 3
- Diagnostic Products Corp. 3
- Abbott Laboratories 3
- Hybritech, Inc. 3
- Micromedic Systems 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Ciba Corning Diagnostics Corp. 2
- Diagnostic Systems Laboratories, Inc. 2
- Behring Diagnostics, Inc. 2
- Olympus America, Inc. 2
- Nichols Institute Diagnostics 2
- Corning Medical & Scientific 2
- Medix Biotech, Inc. 2
- Roche Diagnostics Corp. 2
- Siemens Healthcare Diagnostics, Inc. 2
- Serono-Baker Diagnostics, Inc. 2
- Beckman Coulter Inc. 2
- New England Immunology Assoc. 2
- DiaSorin, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193650 | LIAISON FerritinDBF · Traditional | DiaSorin, Inc. | 09/14/2021SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | Horiba Abx SAS | 03/06/2020SE |
| K171642 | Atellica IM Ferritin AssayDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/31/2017SE |
| K133083 | Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control SetDBF · Traditional | Diazyme Laboratories | 06/24/2014SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | Kamiya Biomedical Company | 05/24/2012SE |
| K110736 | Advia Chemistry Ferritin (FRT) MethodDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/17/2011SE |
| K100538 | Tina-Quant Ferritin Gen. 4DBF · Traditional | Roche Diagnostics | 06/22/2010SE |
| K092505 | Beckman Coulter Ferritin Reagent, Model: OSR61203DBF · Traditional | Beckman Coulter, Inc. | 12/11/2009SE |
| K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279DBF · Traditional | Medicon Hellas S.A | 11/20/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | Reference Diagnostics, Inc. | 03/13/2006SE |
| K052617 | Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510…DBF · Traditional | Good Biotech Corp. | 02/23/2006SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | Kamiya Biomedical Co. | 12/23/2005SE |
| K040879 | Quantex FerritinDBF · Traditional | Instrumentation Laboratory CO | 05/10/2004SE |
| K031650 | Ferritin Generation 2DBF · Traditional | Roche Diagnostics Corp. | 07/17/2003SE |
| K030124 | Olympus Ferritin ReagentDBF · Special | Olympus America, Inc. | 02/06/2003SE |
| K014293 | K-Assay Ferritin, K-Assay Ferritin Calibrator SetDBF · Traditional | Kamiya Biomedical Co. | 02/19/2002SE |
| K000662 | Randox FerritinDBF · Traditional | Randox Laboratories, Ltd. | 04/03/2000SE |
| K993273 | N Latex FerritinDBF · Traditional | Dade Behring, Inc. | 11/23/1999SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | Biocheck, Inc. | 09/24/1999SE |
| K992157 | Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional | Chiron Diagnostics Corp. | 08/05/1999SE |
| K984186 | Nichols Advantage Chemiluminescence Ferritin ImmunoassayDBF · Traditional | Nichols Institute Diagnostics | 02/02/1999SE |
| K983340 | Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System…DBF · Traditional | Beckman Coulter, Inc. | 12/14/1998SE |
| K983759 | Abbott Architect FerritinDBF · Traditional | Abbott Laboratories | 12/07/1998SE |
| K982714 | Bayer Immuno 1 System Ferritin AssayDBF · Traditional | Bayer Corp. | 10/22/1998SE |
| K974505 | Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501DBF · Traditional | Alfa Biotech (Uk) , Ltd. | 02/17/1998SE |
| K973331 | Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators…DBF · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/22/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | Behring Diagnostics, Inc. | 09/12/1997SE |
| K970612 | Sealite Sciences, Inc. Aqualite Ferritin AssayDBF · Traditional | Sealite Sciences, Inc. | 06/24/1997SE |
| K963170 | Olympus Ferritin Immunoturbidimetric ReagentDBF · Traditional | Olympus America, Inc. | 12/02/1996SE |
| K951993 | Ubi Magiwel Ferritin QuantitativeDBF · Traditional | United Biotech, Inc. | 07/05/1995SE |
| K952286 | Amerlite Ferritin II AssayDBF · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 06/20/1995SE |
| K950707 | N Latex FerritinDBF · Traditional | Behring Diagnostics, Inc. | 03/27/1995SE |
| K935847 | Axsym FerritinDBF · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935528 | Dupont Aca(R) Plus Immunoassay Sys Ferritin(Ferr) MethDBF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/28/1994SE |
| K931576 | Vista Ferritin AssayDBF · Traditional | Syva Co. | 08/05/1993SE |
| K924858 | Aia-Pack Fer Calibration Verification Test SetDBF · Traditional | Tosoh Medics, Inc. | 12/15/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | Vitek Systems, Inc. | 04/07/1992SE |
| K920046 | Modified Ferritin Enzyme Imunoassay Test KitDBF · Traditional | Medix Biotech, Inc. | 01/28/1992SE |
| K911175 | Sri Ferritin Immoenzymetric Assay(Mag Solid-Phase)DBF · Traditional | Serono-Baker Diagnostics, Inc. | 04/05/1991SE |
| K905770 | Ciba Corning Acs Ferritin ImmunoassayDBF · Traditional | Ciba Corning Diagnostics Corp. | 03/12/1991SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | Bioclone Australia Pty , Ltd. | 11/29/1990SE |
| K901075 | Lumatag(Tm) Ferritin Chemiluminescence Immunomet.DBF · Traditional | London Diagnostics, Inc. | 04/02/1990SE |
| K896585 | Modified Ferritin Enzyme Immunoassay Test KitDBF · Traditional | Medix Biotech, Inc. | 12/04/1989SE |
| K895872 | LAN.0800Q/2800QDBF · Traditional | Amersham Corp. | 10/17/1989SE |
| K892362 | Amerlite Ferritin Assay (Additional Protocol)DBF · Traditional | Amersham Corp. | 05/09/1989SE |
| K885074 | Affinity(Tm) Ferritin Immunit(Tm)DBF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/04/1989SE |
| K884683 | Ferritin Serozyme Immunoenzymetric AssayDBF · Traditional | Serono-Baker Diagnostics, Inc. | 12/27/1988SE |
| K883746 | Micromedic Ferritin Irma KitDBF · Traditional | Icn Micromedic Systems | 10/27/1988SE |
| K874203 | Amerlite Ferritin Assay, LAN.0800/1800/2800DBF · Traditional | Amersham Corp. | 01/27/1988SE |
| K874572 | Allegro (TM) Ferritin Immunoassay SystemDBF · Traditional | Nichols Institute Diagnostics | 12/02/1987SE |
| K874031 | Irma-Count Ferritin W/Mono. Antibodies RKFE1,2,5DBF · Traditional | Diagnostic Products Corp. | 11/25/1987SE |
| K873573 | Ciba Corning Magic Lite FerritinDBF · Traditional | Ciba Corning Diagnostics Corp. | 10/07/1987SE |
| K871489 | DSL 5400 Active (TM) Ferritin Eia SystemDBF · Traditional | Diagnostic Systems Laboratories, Inc. | 06/12/1987SE |
| K870570 | Ferritin Mab Solid Phase Component SystemDBF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/12/1987SE |
| K870107 | Coat-A-Count Irma Ferritin Kit and Its ComponentsDBF · Traditional | Diagnostic Products Corp. | 02/10/1987SE |
| K864437 | Beckman Epsilon(Tm) Ferritin Test KitDBF · Traditional | Beckman Instruments, Inc. | 01/16/1987SE |
| K863345 | Tandem(R)-M Ferritin Immunoenzymetric AssayDBF · Traditional | Hybritech, Inc. | 10/08/1986SE |
| K863487 | Quantimune(R) Ferritin IrmaDBF · Traditional | Bio-Rad | 10/01/1986SE |
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | Medical & Scientific Designs, Inc. | 08/27/1986SE |
| K862014 | Immpulse Ferritin Assay ReagentDBF · Traditional | Sclavo, Inc. | 06/19/1986SE |
| K860137 | Enzymun-Test FerritinDBF · Traditional | Boehringer Mannheim Corp. | 03/28/1986SE |
| K844158 | Stratus Ferritin Fluorometric Enzyme ImmunoassayDBF · Traditional | American Dade | 11/19/1984SE |
| K841925 | DSL Ferritin IrmaDBF · Traditional | Diagnostic Systems Laboratories, Inc. | 05/25/1984SE |
| K830580 | Diagnon Ferritin 125 I Ria KitDBF · Traditional | Iagnon Corp. | 05/05/1983SE |
| K830591 | Corning Ferritin 125I RadioimmunoassayDBF · Traditional | Corning Medical & Scientific | 03/24/1983SE |
| K823871 | Tandem-E -Fer Immunoenzymetric KitDBF · Traditional | Hybritech, Inc. | 02/25/1983SE |
| K823275 | Autopak Ferritin Test Delivery SysDBF · Traditional | Micromedic Systems | 12/03/1982SE |
| K822472 | Antisera to Human FerritinDBF · Traditional | Kent Laboratories, Inc. | 09/30/1982SE |
| K812901 | 125I Ferritin Radioimmunoassay KitDBF · Traditional | Bio-Ria | 12/30/1981SE |
| K812786 | FERRITIN(125I) Radioimmunoassay Test SysDBF · Traditional | Corning Medical & Scientific | 10/23/1981SE |
| K812597 | Ferritin KitDBF · Traditional | Hybritech, Inc. | 10/19/1981SE |
| K812056 | Spectro FeiritinDBF · Traditional | Ramco Laboratories, Inc. | 08/12/1981SE |
| K811880 | Leeco Ferritin-Quant Diag. Test KitDBF · Traditional | Leeco Diagnostics, Inc. | 07/16/1981SE |
| K811808 | AUTOPAK-12 Ferritin KitDBF · Traditional | Micromedic Systems | 07/10/1981SE |
| K811804 | Ferritin Ria KitDBF · Traditional | Amersham Corp. | 07/10/1981SE |
| K801989 | Nordiclab Ferritin Irma TestDBF · Traditional | Nordiclab Intl. | 09/16/1980SE |
| K801676 | Ferrizyme Ferritin Enzyme ImmunoassayDBF · Traditional | Abbott Laboratories | 08/20/1980SE |
| K801580 | Ferritin Ria KitDBF · Traditional | Diagnostic Products Corp. | 08/13/1980SE |
| K800657 | Ferritin Controls Code QAS.104DBF · Traditional | Amersham Corp. | 04/16/1980SE |
| K800299 | Ferritin Ria KitDBF · Traditional | Amersham Corp. | 03/03/1980SE |
| K792449 | Centria Ferritin RiaDBF · Traditional | Union Carbide Corp. | 12/31/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 12/18/1979SE |
| K791860 | Ferritin Ria KitDBF · Traditional | Cis Radiopharmaceuticals, Inc. | 12/06/1979SE |
| K790490 | Neia-Ferritin Enzymeimmunassay KitDBF · Traditional | New England Immunology Assoc. | 04/23/1979SE |
| K790447 | Ventre/Sep Ferritin RiaDBF · Traditional | Ventrex Laboratories, Inc. | 04/23/1979SE |
| K780490 | Neia-Ferritin EnzymeimmunoassayDBF · Traditional | New England Immunology Assoc. | 04/10/1978SE |
| K770702 | In Vitro Ferritin Ria TestDBF · Traditional | Clinical Assays, Inc. | 06/17/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2208-2019 Class II | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a…Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | Abbott Ireland Diagnostics Division | 11/21/2018Terminated |
| Z-2096-2018 Class II | ST-AIA PACK Fer; Part Number: 025253 Assay, AnemiaAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2609-2017 Class II | Dimension Vista Ferritin (FERR) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | Siemens Healthcare Diagnostics, Inc. | 03/21/2017Terminated |
| Z-0130-2015 Class II | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA…Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the… | Siemens Healthcare Diagnostics, Inc | 10/09/2012Terminated |
| Z-0129-2015 Class II | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA…Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the… | Siemens Healthcare Diagnostics, Inc | 10/09/2012Terminated |
| Z-0128-2015 Class II | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the…Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the… | Siemens Healthcare Diagnostics, Inc | 10/09/2012Terminated |