Product code DDC
- Device name
- Thyroglobulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5870
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Quest Intl., Inc. | 2003-01-06 |
| K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 | Beckman Coulter, Inc. | 2001-09-07 |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2000-02-18 |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-06-25 |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-06-17 |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Monobind | 1997-07-03 |
| K953066 | SERODIA ATG | Fujirebio America, Inc. | 1995-08-14 |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1994-12-22 |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Biomerica, Inc. | 1994-07-18 |
| K930486 | QUANTA LITE(TM) THYROID T ELISA | Inova Diagnostics, Inc. | 1993-03-15 |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | Miles Laboratories, Inc. | 1987-02-02 |
| K780873 | THYMUNE-M | Burroughs Wellcome Co. | 1978-06-14 |
| K780874 | THYMUNE-T | Burroughs Wellcome Co. | 1978-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474041101 | Anti-Thyroglobulin (Anti-Tg) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474027914 | TPO IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239027894 | Cardiolipin IgM ELISA | DRG International Inc | 2023-08-24 |
| 00840239027917 | TPO IgG ELISA | DRG International Inc | 2023-08-24 |
| 00840239041104 | Anti-Thyroglobulin (Anti-Tg) ELISA | DRG International Inc | 2019-03-20 |
| 00816870020389 | Anti-Tg AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022062 | Anti-Tg AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 05056080500027 | NA | REMEL EUROPE LIMITED | 2016-12-09 |
| 05056080500034 | NA | REMEL EUROPE LIMITED | 2016-12-09 |
| 00816879020038 | Autostat II Anti-Thyroglobulin | HYCOR BIOMEDICAL LLC | 2016-09-26 |
| 08426950454465 | QUANTA Lite® Thyroid T ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 00850487007241 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007494 | SeraQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |