Thyroglobulin, Antigen, Antiserum, Control
FDA product code DDC · Class II (moderate risk) · 21 CFR 866.5870 · Immunology
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | Quest Intl., Inc. | 01/06/2003SE |
| K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models…DDC · Traditional | Beckman Coulter, Inc. | 09/07/2001SE |
| K000363 | Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Special | Zeus Scientific, Inc. | 02/18/2000SE |
| K991610 | Zeus Scientific Inc., Tpo Igg Elisa Test System.DDC · Traditional | Zeus Scientific, Inc. | 06/25/1999SE |
| K991179 | Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Traditional | Zeus Scientific, Inc. | 06/17/1999SE |
| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | Monobind | 07/03/1997SE |
| K953066 | Serodia AtgDDC · Traditional | Fujirebio America, Inc. | 08/14/1995SE |
| K943625 | Autostat II Anti-ThyroglobulinDDC · Traditional | Cogent Diagnotics , Ltd. | 12/22/1994SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | Biomerica, Inc. | 07/18/1994SE |
| K930486 | Quanta Lite(Tm) Thyroid T ElisaDDC · Traditional | Inova Diagnostics, Inc. | 03/15/1993SE |
| K865020 | Sera-Tek Thyroglobulin Antibody TestDDC · Traditional | Miles Laboratories, Inc. | 02/02/1987SE |
| K780874 | Thymune-TDDC · Traditional | Burroughs Wellcome Co. | 06/14/1978SE |
| K780873 | Thymune-MDDC · Traditional | Burroughs Wellcome Co. | 06/14/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0417-2007 | Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level… | Beckman Coulter Inc | 10/26/2006Terminated |