Radioimmunoassay, Total Thyroxine
FDA product code CDX · Class II (moderate risk) · 21 CFR 862.1700 · Clinical Chemistry
121510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Abbott Laboratories 6
- Bd Becton Dickinson Vacutainer Systems Preanalytic 6
- Bio-Rad 4
- Micromedic Systems 4
- Miles Laboratories, Inc. 4
- Syva Co. 4
- Diagnostic Products Corp. 4
- Nuclear Diagnostics, Inc. 3
- Pcl-Ria, Inc. 3
- Clinical Assays, Inc. 3
- Ciba Corning Diagnostics Corp. 3
- G.D. Searle and Co. 2
- Technicon Instruments Corp. 2
- Monobind 2
- Neometrics, Inc. 2
- E. R. Squibb & Sons, Inc. 2
- Mallinckrodt Critical Care 2
- Corning Medical & Scientific 2
- Boehringer Mannheim Corp. 2
- American Dade 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961490 | Elecsys T4 AssayCDX · Traditional | Boehringer Mannheim Corp. | 06/13/1996SE |
| K954312 | Active Thyroxine RiaCDX · Traditional | Diagnostic Systems Laboratories, Inc. | 10/07/1995SE |
| K943416 | Delfia Neonatal Thyroxine KitCDX · Traditional | Wallac OY | 03/10/1995SE |
| K934384 | Axsym(Tm) Total T4CDX · Traditional | Abbott Laboratories | 06/21/1994SE |
| K932980 | Total T4 Fpia Reagent Set/Calibrator #T-1039,T-116CDX · Traditional | Sigma Diagnostics, Inc. | 10/18/1993SE |
| K933426 | Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional | Baxter Diagnostics, Inc. | 08/26/1993SE |
| K931295 | Iq TT4 AssayCDX · Traditional | Becton Dickinson Advanced Diagnostics | 07/20/1993SE |
| K926563 | Autobead(Tm) T4 Enzyme Immunoassay Test KitCDX · Traditional | Bio-Chem Laboratory Systems, Inc. | 03/18/1993SE |
| K925110 | Abbott Imx T4CDX · Traditional | Abbott Laboratories | 01/26/1993SE |
| K925109 | Abbott Tdx/Tdxflx TT4CDX · Traditional | Abbott Laboratories | 01/04/1993SE |
| K922945 | Technicon Dax System Thyroxine (T4) MethodCDX · Traditional | Heraeus Kulzer, Inc. | 10/14/1992SE |
| K921935 | Thyroxine (T4) Coated Tube RiaCDX · Traditional | Monobind | 07/07/1992SE |
| K920766 | T4 Eia Bead AssayCDX · Traditional | Tech-Co, Inc. | 04/17/1992SE |
| K915235 | Clinical Assays Gamma Coat Free T4 Radioimm. KitCDX · Traditional | Incstar Corp. | 01/28/1992SE |
| K912541 | Milenia Total T4, Catalog: MKT41,5CDX · Traditional | Diagnostic Products Corp. | 08/12/1991SE |
| K911985 | Lumatag T4 Chemiluminescence AssayCDX · Traditional | London Diagnostics, Inc. | 08/02/1991SE |
| K904816 | Thyroxine Monoclonal Antibody Solid Phase RadioimmCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/17/1991SE |
| K905532 | Ciba Corning Acs T4 ImmunoassayCDX · Traditional | Ciba Corning Diagnostics Corp. | 01/15/1991SE |
| K902922 | Microzyme T4 Enzyme Immunoassay KitCDX · Traditional | Immunotech Corp. | 07/27/1990SE |
| K901475 | Clinical Assays(Tm) Gammacoat(Tm) M [125I] T4CDX · Traditional | Baxter Healthcare Corp | 06/20/1990SE |
| K901939 | Neocoat T4CDX · Traditional | Neometrics, Inc. | 05/31/1990SE |
| K894575 | Technicon Ra System Thyroxine T4 MethodCDX · Traditional | Technicon Instruments Corp. | 10/04/1989SE |
| K883559 | Delfia Thyroxine (T4) KitCDX · Traditional | Pharmacia, Inc. | 12/14/1988SE |
| K874623 | Fiagen(Tm) Thyroxine (T4), Catalogue #101-101CDX · Traditional | Cyberfluor, Inc. | 02/16/1988SE |
| K875081 | Immpulse T4 Assay ReagentsCDX · Traditional | Sclavo, Inc. | 02/11/1988SE |
| K872286 | Ciba Corning Magic Lite FT4 ImmunoassayCDX · Traditional | Ciba Corning Diagnostics Corp. | 07/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | Lkb Instruments, Inc. | 06/17/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | Micromedic Systems | 05/26/1987SE |
| K870965 | Ciba Corning Magic(R) Lite T4 ImmunoassayCDX · Traditional | Ciba Corning Diagnostics Corp. | 05/14/1987SE |
| K870573 | T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional | Cambridge Medical Technology | 04/22/1987SE |
| K864560 | Iq T4 ImmunoassayCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/16/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | Micromedic Systems | 04/24/1986SE |
| K860421 | Strat Total Thyroxine Fluoromet Enzyme ImmunoassayCDX · Traditional | American Dade | 02/11/1986SE |
| K854798 | T-4 RiassayCDX · Traditional | Ria Diagnostics | 01/15/1986SE |
| K854324 | Pancoat T4 Coated Tube Radioimmunoassay KitCDX · Traditional | Pantex, Div. Bio-Analysis, Inc. | 12/05/1985SE |
| K840852 | Immpulse T4 Assay ReagentsCDX · Traditional | Paragon Diagnostics, Inc. | 04/18/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | Biosan Laboratories, Inc. | 01/24/1984SE |
| K833850 | T4 RiaCDX · Traditional | Syncor Intl. Corp. | 01/18/1984SE |
| K833745 | Riacoat T-4CDX · Traditional | Immuno Assay Corp. | 01/04/1984SE |
| K832468 | T4-RIA Single ReagentCDX · Traditional | Fairlake Laboratories | 09/12/1983SE |
| K831533 | Magic T4 125I RadioimmunoassayCDX · Traditional | Corning Medical & Scientific | 06/30/1983SE |
| K831107 | Coat-A-Count Neonatal T4 Kit Ria KitCDX · Traditional | Diagnostic Products Corp. | 05/18/1983SE |
| K830642 | Phase Thyroxine Radioimmunoassay KitCDX · Traditional | Medical & Scientific Designs, Inc. | 04/05/1983SE |
| K823265 | Monoclonal Antibody T4 Radio-KitCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/09/1982SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | Nuclear Medical Laboratories, Inc. | 11/10/1982SE |
| K823004 | Bio Mag Total T4 Radioimmunoassay KitCDX · Traditional | Bioclinical Group | 11/05/1982SE |
| K822399 | Leeco T4 Quant Diagnostics Test KitCDX · Traditional | Leeco Diagnostics, Inc. | 09/13/1982SE |
| K821554 | Zetaphase T4 Radioimmunoassay Diag. KitCDX · Traditional | Amf Biological and Diagnostics Co. | 06/25/1982SE |
| K820725 | Spac T4 Ria Test KitCDX · Traditional | Mallinckrodt Critical Care | 06/01/1982SE |
| K821141 | Endab T4 Enzyme Immunoassay KitCDX · Traditional | Immunotech Corp. | 05/13/1982SE |
| K821101 | Total Radioimmunoassay KitCDX · Traditional | Bioclinical Group | 05/05/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | Pcl-Ria, Inc. | 04/16/1982SE |
| K811787 | Quantaphase T-4 RiaCDX · Traditional | Bio-Rad | 07/10/1981SE |
| K811315 | Coat-A-Count T4 Ria KitCDX · Traditional | Diagnostic Products Corp. | 05/27/1981SE |
| K811070 | 125 I-T4 Ria Test KitCDX · Traditional | Intl. Immunoassay Laboratories, Inc. | 04/29/1981SE |
| K810811 | T4 Ria KitCDX · Traditional | Immuno Assay Corp. | 04/07/1981SE |
| K803046 | Immu-Trace T4 Ria ProcedureCDX · Traditional | American Dade | 01/02/1981SE |
| K802573 | Serum T4 by Enzyme ImmunoassayCDX · Traditional | Worthington Diagnostic Systems | 11/24/1980SE |
| K802469 | T4 Radioimmunoassay KitCDX · Traditional | American Diagnostic Corp. | 11/12/1980SE |
| K802456 | T4-SQUIBB Ria KitCDX · Traditional | E. R. Squibb & Sons, Inc. | 10/31/1980SE |
| K801105 | Thyroxine Radioimmunoassay KitCDX · Traditional | Calbiochem-Behring Corp. | 06/09/1980SE |
| K800385 | Analyte T4-THYROXINECDX · Traditional | Technicon Instruments Corp. | 03/19/1980SE |
| K800203 | Ria Phase T4CDX · Traditional | Boehringer Mannheim Corp. | 03/19/1980SE |
| K800300 | Amerlex T-4 Ria KitCDX · Traditional | Amersham Corp. | 03/05/1980SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | Endocrine-Metabolic Center | 02/13/1980SE |
| K800169 | Ames Rialyze - Chromatography TubesCDX · Traditional | Miles Laboratories, Inc. | 02/13/1980SE |
| K792599 | TIPSEP-T4(RIA) T4 RadioimmunoassayCDX · Traditional | Nuclear Diagnostics, Inc. | 01/16/1980SE |
| K792188 | Tetrabead - 125 T4 Solid Phase Diag. KitCDX · Traditional | Abbott Laboratories | 11/27/1979SE |
| K791664 | Immuchem Covalent Coat Solid Phase AssayCDX · Traditional | Immuchem Corp. | 09/27/1979SE |
| K791368 | Ventre/Sep T4 Test SetCDX · Traditional | Ventrex Laboratories, Inc. | 09/17/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | Burroughs Wellcome Co. | 09/04/1979SE |
| K790576 | Quantimune T-4 FiaCDX · Traditional | Bio-Rad | 07/30/1979SE |
| K790907 | Autopak Test Delivery SystemCDX · Traditional | Micromedic Systems | 06/27/1979SE |
| K790800 | Centria T4 Ria Test SetCDX · Traditional | Ventrex Laboratories, Inc. | 06/15/1979SE |
| K790665 | Neonatal Ty Autopak Test Delivery SystemCDX · Traditional | Micromedic Systems | 05/15/1979SE |
| K790495 | Thyroxine Ria KitCDX · Traditional | Technia Diagnostics , Ltd. | 05/03/1979SE |
| K790477 | Ty Ria Kit, Automated Assay SystemCDX · Traditional | E. R. Squibb & Sons, Inc. | 04/26/1979SE |
| K782109 | Ria Kit, GammacoatCDX · Traditional | Clinical Assays, Inc. | 01/26/1979SE |
| K782103 | Ria Kit, Neonatal T4CDX · Traditional | Serono Laboratories, Inc. | 01/17/1979SE |
| K781222 | Accuscreen T4CDX · Traditional | Neometrics, Inc. | 11/08/1978SE |
| K781483 | ORTHO*T-4 Ria (Peg) KitCDX · Traditional | Ortho Diagnostics, Inc. | 09/27/1978SE |
| K781235 | IV Vitro Gammadab T4 Ria KitCDX · Traditional | Clinical Assays, Inc. | 08/14/1978SE |
| K781182 | Micro Thyroxine Reagent SystemCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/14/1978SE |
| K781181 | Cliniria Total T-4 (Ria) TestCDX · Traditional | Miles Laboratories, Inc. | 08/14/1978SE |
| K780854 | In Vitro Neonatal T4CDX · Traditional | Clinical Assays, Inc. | 07/27/1978SE |
| K780707 | T4-RIA KitCDX · Traditional | Clinical Bioresearch | 06/14/1978SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | Radioimmunoassay, Inc. | 06/06/1978SE |
| K780639 | Emit Centrifichem Thyroxine AssayCDX · Traditional | Syva Co. | 05/03/1978SE |
| K780644 | Radioassay for Total Serum ThyroxineCDX · Traditional | Nuclear Diagnostics, Inc. | 04/28/1978SE |
| K780401 | THYRO-ZYME-T4 Assay KitCDX · Traditional | Coulter Electronics, Inc. | 04/24/1978SE |
| K780308 | OREIA-T4CDX · Traditional | Organon, Inc. | 04/12/1978SE |
| K780423 | STIKSEP-T4 Ria KitCDX · Traditional | Nuclear Diagnostics, Inc. | 03/30/1978SE |
| K780121 | Reagents, Manueal, Assay, ThyroxineCDX · Traditional | Syva Co. | 03/17/1978SE |
| K780219 | Analysis Sys., Emit Man. Thyroxine AssayCDX · Traditional | Syva Co. | 03/03/1978SE |
| K780050 | Thyroxine Stds. in Human SerumCDX · Traditional | Pcl-Ria, Inc. | 02/13/1978SE |
| K772330 | T4 Ria KitCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/12/1978SE |
| K771415 | Ria for Serum ThyroxineCDX · Traditional | Clinical Immuno-Diagnostics | 01/05/1978SE |
| K772170 | Emit Centrifichem Thyroxine AssayCDX · Traditional | Syva Co. | 12/22/1977SE |
| K771609 | Pediatric Thyroxine Test Sys. T4CDX · Traditional | Corning Medical & Scientific | 12/20/1977SE |
| K772096 | In Vitro Diagnostic ReagentCDX · Traditional | Pcl-Ria, Inc. | 11/22/1977SE |
| K772064 | THYRODOT-4 Antisera LyopholizedCDX · Traditional | Medcom Diagnostics, Inc. | 11/14/1977SE |
| K772014 | Ames T-4 Strip TestCDX · Traditional | Miles Laboratories, Inc. | 11/02/1977SE |
| K771414 | T4 by Ria Diag. KitCDX · Traditional | Biomedical Labs., Inc. | 09/22/1977SE |
| K771606 | Immunospot Neonatal T4 TestCDX · Traditional | Meloy Laboratories, Inc. | 09/15/1977SE |
| K771221 | T4 Ria Test SystemCDX · Traditional | Monobind | 08/04/1977SE |
| K771309 | Ria for Total ThyroxineCDX · Traditional | Abbott Laboratories | 08/03/1977SE |
| K771135 | Quantimune Neonatal & Thyroxine RiaCDX · Traditional | Bio-Rad | 07/14/1977SE |
| K770733 | Reagent System, Thyroxine, AriaCDX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/24/1977SE |
| K770940 | Total Thyroxine (Ria) Reagent SetCDX · Traditional | The Dow Chemical Co. | 06/22/1977SE |
| K770737 | Reagent Set, T-4, CPBCDX · Traditional | G.D. Searle and Co. | 06/22/1977SE |
| K770676 | T-4 Ria Reagent SetCDX · Traditional | G.D. Searle and Co. | 05/20/1977SE |
| K770726 | Ria Kit, T4 ClaspCDX · Traditional | Squibb & Sons, Inc. | 04/28/1977SE |
| K770474 | Thyroscreen TM T4 Diagnostic KitCDX · Traditional | Abbott Laboratories | 04/28/1977SE |
| K761272 | Centria T4 RiaCDX · Traditional | Clinical Diagnostics, Inc. | 03/16/1977SE |
| K770241 | Neonatal T4 Ria KitCDX · Traditional | Diagnostic Products Corp. | 02/14/1977SE |
| K770156 | Spac TM T4 Ria KitCDX · Traditional | Mallinckrodt Critical Care | 02/07/1977SE |
| K761282 | Data-Tope T4 Ria ProcedureCDX · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 12/30/1976SE |
| K760572 | SeraluteCDX · Traditional | Miles Laboratories, Inc. | 11/23/1976SE |
| K760227 | RadioimmunoassayCDX · Traditional | Kallestad Laboratories, Inc. | 07/26/1976SE |
| K760135 | Test, Ra, Quanta-Count T-4CDX · Traditional | Bio-Rad | 07/20/1976SE |
| K760079 | Reagent, Thyroxine T4 (#210)CDX · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2265-2025 Class III | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568…An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis… | DRG International, Inc. | 06/04/2025Open, Classified |