Radioimmunoassay (Two-Site Solid Phase), Ferritin
FDA product code JMG · Class II (moderate risk) · 21 CFR 866.5340 · Immunology
24510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Beckman Coulter Inc. 2
- Boehringer Mannheim Corp. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Corning Medical & Scientific 2
- Diagnostic Products Corp. 2
- Baxter Healthcare Corp 1
- Dade Chemistry Systems, Inc. 1
- Schiapparelli Biosystems, Inc. 1
- Bio-Rad Laboratories, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- Microgenics Corp. 1
- Cambridge Medical Technology 1
- Calbiochem-Behring Corp. 1
- Medix Biotech, Inc. 1
- Lkb Instruments, Inc. 1
- Bio-Rad 1
- Nordiclab Intl. 1
- New England Nuclear 1
- Ria Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234052 | Access FerritinJMG · Traditional | Beckman Coulter, Inc. | 03/20/2024SE |
| K052082 | Ferritin on the Access Immunoassay Systems, Model 33020JMG · Special | Beckman Coulter, Inc. | 08/19/2005SE |
| K964282 | Tina-Quant Ferritin AssayJMG · Traditional | Boehringer Mannheim Corp. | 07/30/1997SE |
| K971833 | Elecsys FerritinJMG · Traditional | Boehringer Mannheim Corp. | 06/02/1997SE |
| K963498 | Ferr Flex Reagent CartridgeJMG · Traditional | Dade Chemistry Systems, Inc. | 01/24/1997SE |
| K950393 | Ace(Tm) Cedia(R) Ferritin AssayJMG · Traditional | Schiapparelli Biosystems, Inc. | 05/16/1995SE |
| K926221 | Access Ferritin AssayJMG · Traditional | Bio-Rad Laboratories, Inc. | 01/13/1993SE |
| K925848 | Immulite FerritinJMG · Traditional | Diagnostic Products Corp. | 01/13/1993SE |
| K920829 | Cobas Core Ferritin EiaJMG · Traditional | Roche Diagnostic Systems, Inc. | 06/19/1992SE |
| K920318 | Cedia Ferritin AssayJMG · Traditional | Microgenics Corp. | 06/04/1992SE |
| K902997 | Milenia (TM) FerritinJMG · Traditional | Diagnostic Products Corp. | 08/02/1990SE |
| K890697 | Ria-Gnost FerritinJMG · Traditional | Cambridge Medical Technology | 03/16/1989SE |
| K881138 | Clinical Assays Gammacoat [125I] Ferritin Immuno.JMG · Traditional | Baxter Healthcare Corp | 04/21/1988SE |
| K873730 | Medix Biotech Ferritin Enzyme Immunoassay Test KitJMG · Traditional | Medix Biotech, Inc. | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | Lkb Instruments, Inc. | 08/21/1987SE |
| K840460 | Cornings Magic Ferritin Radioimmuno-JMG · Traditional | Corning Medical & Scientific | 03/30/1984SE |
| K810799 | Quantimune Ferritin IrmaJMG · Traditional | Bio-Rad | 04/03/1981SE |
| K792588 | Territin Ria KitJMG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/11/1980SE |
| K791096 | Radioimmunoassay Test SystemJMG · Traditional | Corning Medical & Scientific | 08/03/1979SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | Nordiclab Intl. | 01/17/1979SE |
| K781946 | Ria Kit, Ferritin Solid PhaseJMG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/10/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | New England Nuclear | 01/10/1979SE |
| K781844 | Ferritin KitJMG · Traditional | Ria Products, Inc. | 01/10/1979SE |
| K781527 | Ria System for Human Fe-RitinJMG · Traditional | Calbiochem-Behring Corp. | 10/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0809-2026 Class II | Heavy Metals TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2229-2019 Class II | Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex…Negative Bias with Lot EA9227. | Siemens Healthcare Diagnostics, Inc. | 07/15/2019Terminated |
| Z-1833-2017 Class II | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136CBeckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with… | Beckman Coulter Inc. | 03/10/2017Terminated |
| Z-2238-2014 Class II | Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system…Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and… | Siemens Healthcare Diagnostics, Inc. | 07/15/2014Terminated |
| Z-0561-2014 Class II | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product…Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result… | Siemens Healthcare Diagnostics, Inc. | 05/06/2013Terminated |