Product code JNL
- Device name
- Immunochemical, Thyroglobulin Autoantibody
- 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 |
|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 |
| K112933 | ACCESS THYROGLOBULIN ANITBODY | Beckman Coulter, Inc. | 2011-12-27 |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | 2007-11-20 |
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) | Beckman Coulter, Inc. | 2006-10-05 |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Monobind | 1997-07-03 |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | 1996-11-25 |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | 1996-11-25 |
| K954256 | ANTI-TPO | Biomerica, Inc. | 1995-11-27 |
| K951362 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 |
| K951364 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | 1995-08-25 |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | 1995-08-25 |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | 1995-04-17 |
| K941358 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 |
| K941361 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 |
| K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | Nichols Institute | 1993-04-08 |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1992-09-22 |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | Cogent Diagnotics , Ltd. | 1992-09-22 |
| K921787 | SYNELISA TPO ANTIBODIES | Elias U.S.A., Inc. | 1992-07-28 |
| K905486 | IMMUNOWELL TPO (MICROSOME) TEST | General Biometrics, Inc. | 1991-01-03 |
| K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL | General Biometrics, Inc. | 1990-10-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474041149 | Anti-Thyroid Peroxidase (Anti-TPO) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00840239041142 | Anti-Thyroid Peroxidase (Anti-TPO) ELISA | DRG International Inc | 2019-03-20 |
| 00816870020396 | Anti-TPO AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022079 | Monobind AccuLite Anti-TPO CLIA Kit - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816879020045 | Autostat II Anti-Thyroid Peroxidase | HYCOR BIOMEDICAL LLC | 2016-09-26 |
| 00613745030203 | ImmunoWELL TPO IgG Quantitative Test | GenBio | 2016-09-24 |
| 00613745030302 | ImmunoWELL Thyroglobulin IgG Quantitative Test | GenBio | 2016-09-24 |
| 00613745039121 | ImmunoDOT Thyroid Positive Control | GenBio | 2016-09-24 |
| 00613745058252 | ImmunoDOT Thyroid Autoimmunity Panel | GenBio | 2016-09-24 |
| 00613745058894 | ImmunoDOT Thyroid Autoimmunity Panel | GenBio | 2016-09-24 |
| 07333066003993 | ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin | Phadia AB | 2016-09-23 |
| 07333066004006 | ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin | Phadia AB | 2016-09-23 |
| 05391516743808 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-22 |
| 15099590202910 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2016-09-09 |