Radioimmunoassay, Thyroxine-Binding Globulin
FDA product code CEE · Class II (moderate risk) · 21 CFR 862.1685 · Clinical Chemistry
25510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Nuclear Diagnostics, Inc. 3
- Boehringer Mannheim Corp. 3
- Immunotech Corp. 2
- Johnson & Johnson Clinical Diagnostics, Inc. 1
- Bio-Rad 1
- Bio-Rad Laboratories, Inc. 1
- Cirrus Diagnostics, Inc. 1
- Pharmacia, Inc. 1
- Amersham Corp. 1
- Diamedix Corp. 1
- Cyberfluor, Inc. 1
- Technicon Instruments Corp. 1
- Syncor Intl. Corp. 1
- Nichols Institute Diagnostics 1
- Ventrex Laboratories, Inc. 1
- Diagnostic Reagents, Inc. 1
- Clinical Assays, Inc. 1
- Hyland Therapeutic Div., Travenol Laboratories 1
- Radioimmunoassay, Inc. 1
- Corning Medical & Scientific 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952284 | Amerlite TBG AssayCEE · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 07/26/1995SE |
| K930010 | Access Thyroid Uptake AssayCEE · Traditional | Bio-Rad Laboratories, Inc. | 06/07/1993SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | Cirrus Diagnostics, Inc. | 04/29/1991SE |
| K905777 | Microzyme Thyroid Uptake Enzyme Immunoassay KitCEE · Traditional | Immunotech Corp. | 01/30/1991SE |
| K900240 | Delfia TBG KitCEE · Traditional | Pharmacia, Inc. | 03/30/1990SE |
| K896991 | Enzymun Test(R) TBKCEE · Traditional | Boehringer Mannheim Corp. | 03/01/1990SE |
| K893469 | Amerlite TBG Assay, LAN.0005/1005 240/144 Test KitCEE · Traditional | Amersham Corp. | 08/15/1989SE |
| K885034 | T-Uptake MicroassayCEE · Traditional | Diamedix Corp. | 02/02/1989SE |
| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | Cyberfluor, Inc. | 12/14/1988SE |
| K874658 | Technicon Ra(R) Analyte (TBG) (30 C and 37 C)CEE · Traditional | Technicon Instruments Corp. | 12/18/1987SE |
| K862109 | Enzymun Test TBGCEE · Traditional | Boehringer Mannheim Corp. | 06/30/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | Nuclear Diagnostics, Inc. | 06/13/1986SE |
| K842167 | TBG RiaCEE · Traditional | Syncor Intl. Corp. | 07/09/1984SE |
| K842010 | Thyroxine-Binding Globulin RadioummuCEE · Traditional | Nichols Institute Diagnostics | 06/25/1984SE |
| K841024 | Ventrezyme T4U Immunoassay T4UCEE · Traditional | Ventrex Laboratories, Inc. | 05/09/1984SE |
| K822684 | Endab Thyroid UptakeCEE · Traditional | Immunotech Corp. | 10/08/1982SE |
| K820252 | TBG Diagnostic KitCEE · Traditional | Diagnostic Reagents, Inc. | 05/05/1982SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | Clinical Assays, Inc. | 04/23/1981SE |
| K800204 | Ria Phase TBGCEE · Traditional | Boehringer Mannheim Corp. | 03/19/1980SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 08/31/1978SE |
| K780671 | 125 I-T3 Uptake ReagentCEE · Traditional | Radioimmunoassay, Inc. | 06/06/1978SE |
| K780486 | STIKSEP-T3 KitCEE · Traditional | Nuclear Diagnostics, Inc. | 04/28/1978SE |
| K772183 | Thyroid Binding GlobulinCEE · Traditional | Corning Medical & Scientific | 12/20/1977SE |
| K771341 | Spinsep-TbgCEE · Traditional | Nuclear Diagnostics, Inc. | 08/10/1977SE |
| K760134 | Procedure, Ra, Thyroxine Binding ProteinCEE · Traditional | Bio-Rad | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1629-2015 Class II | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of…IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of… | Siemens Healthcare Diagnostics, Inc. | 04/09/2015Terminated |