Product code CDZ
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1680
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026-04-15 |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024-10-23 |
| K233480 | Access SHBG | Beckman Coulter, Inc. | 2024-02-08 |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | 2023-01-13 |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022-05-06 |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | 2020-10-15 |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | 2019-12-20 |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019-01-29 |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018-07-20 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 |
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2016-06-29 |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | 2016-02-11 |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | 2015-12-17 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015-07-02 |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Siemens Healthcare Diagnostics, Inc. | 2014-02-21 |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | DiaSorin, Inc. | 2013-01-25 |
| K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) | Abbott Laboratories | 2012-09-11 |
| K101388 | FASTPACK TESTO IMMUNOASSAY | Qualigen, Inc. | 2011-02-18 |
| K102814 | ELECYSYS SHBG | Roche Diagnostics | 2011-01-20 |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Roche Diagnostics Corp. | 2010-04-23 |
| K091867 | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 | Siemens Healthcare Diagnostics | 2010-01-14 |
| K083867 | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND | Beckman Coulter, Inc. | 2009-08-27 |
| K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 | Biokit, S.A. | 2007-01-23 |
| K052649 | DRG SLV TESTOSTERONE ELISA TEST | Drg Intl., Inc. | 2006-01-27 |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Diagnostic Products Corp. | 2003-10-10 |
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Diagnostics Biochem Canada, Inc. | 2003-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336217832 | Elecsys Testosterone II | Roche Diagnostics GmbH | 2026-04-21 |
| 05060169690721 | IDS-iSYS Total Testosterone | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2026-04-17 |
| 05060169691230 | IDS-iSYS Free Testosterone | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2025-11-03 |
| 04048474015591 | Testosterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 00894175000763 | AccuDiag ™ | Diagnostic Automation, Inc. | 2024-01-30 |
| 00850039602252 | Pantex P635ST | Pantex | 2022-05-23 |
| 00850039602276 | Pantex Universal | Pantex | 2022-05-23 |
| 00850039602269 | Pantex Universal | Pantex | 2022-05-23 |
| 00850039602245 | Pantex P635ST | Pantex | 2022-05-23 |
| 00850039602238 | Pantex P635ST | Pantex | 2022-05-23 |
| 00850039602221 | Pantex P635ST | Pantex | 2022-05-23 |
| 00850039602207 | Pantex P635ST | Pantex | 2022-05-23 |
| 00850039602214 | Pantex P635ST | Pantex | 2022-05-23 |
| 00630414293868 | Atellica IM SHBG | Siemens Healthcare Diagnostics Inc. | 2020-12-12 |
| 04049325006546 | Testosterone Luminescence Immunoassay | IBL International GmbH | 2020-10-20 |
| 04049325003545 | Testosterone Luminescence Immunoassay | IBL International GmbH | 2020-10-20 |
| 04560189213371 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-25 |
| 04560189213388 | AIA-PACK SHBG CONTROL SET | TOSOH CORPORATION | 2019-07-25 |
| 14560189213354 | ST AIA-PACK SHBG | TOSOH CORPORATION | 2019-07-25 |
| 14560189213378 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-25 |
| 14560189213385 | AIA-PACK SHBG CONTROL SET | TOSOH CORPORATION | 2019-07-25 |
| 24560189213351 | ST AIA-PACK SHBG | TOSOH CORPORATION | 2019-07-25 |
| 20816467020345 | FastPack® IP SHBG | QUALIGEN INC. | 2019-03-15 |
| 10816467020348 | FastPack® IP SHBG | QUALIGEN INC. | 2019-02-01 |
| 04015630940516 | Elecsys SHBG | Roche Diagnostics GmbH | 2017-04-21 |
| 00380740003715 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740003708 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740017385 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740017392 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740017415 | ARCHITECT | Abbott GmbH | 2016-06-06 |