| IDS-iSYS Total Testosterone (K252728) | Immunodiagnostic Systems Limited | 2026-04-15 |
| IDS-iSYS Free Testosterone (K240865) | Immunodiagnostic Systems Limited | 2024-10-23 |
| Access SHBG (K233480) | Beckman Coulter, Inc. | 2024-02-08 |
| Access Testosterone (K223405) | Beckman Coulter, Inc. | 2023-01-13 |
| Elecsys Testosterone II (K211685) | Roche Diagnostics | 2022-05-06 |
| LIAISON Testosterone xt (K201908) | DiaSorin, Inc. | 2020-10-15 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| IDS SHBG (K190121) | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| Free Testosterone AccuBind ELISA Test System (K181017) | Monobind, Inc. | 2018-07-20 |
| FREND Testosterone Test System (K153577) | Nanoentek USA, Inc. | 2016-10-14 |
| 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 (K151986) | Siemens Healthcare Diagnostics, Inc. | 2016-06-29 |
| Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator (K151529) | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| ARCHITECT SHBG (K152185) | Biokit, S.A. | 2016-02-11 |
| ARCHITECT 2nd Generation Testosterone (K152155) | Abbott Laboratories | 2015-12-17 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491) | Siemens Healthcare Diagnostics, Inc. | 2014-02-21 |
| LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET (K122793) | DiaSorin, Inc. | 2013-01-25 |
| TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) (K120009) | Abbott Laboratories | 2012-09-11 |
| FASTPACK TESTO IMMUNOASSAY (K101388) | Qualigen, Inc. | 2011-02-18 |
| ELECYSYS SHBG (K102814) | Roche Diagnostics | 2011-01-20 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867) | Siemens Healthcare Diagnostics | 2010-01-14 |
| ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND (K083867) | Beckman Coulter, Inc. | 2009-08-27 |
| ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818) | Biokit, S.A. | 2007-01-23 |
| DRG SLV TESTOSTERONE ELISA TEST (K052649) | Drg Intl., Inc. | 2006-01-27 |
| ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) (K041866) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 |
| IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (K032881) | Diagnostic Products Corp. | 2003-10-10 |
| FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (K030730) | Diagnostics Biochem Canada, Inc. | 2003-08-18 |
| ELECSYS SHBG IMMUNOASSAY (K031717) | Roche Diagnostics Corp. | 2003-08-05 |
| ST AIA-PACK TESTOSTERONE ASSAY (K023091) | Tosoh Medics, Inc. | 2002-12-17 |
| FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY (K021972) | Qualigen, Inc. | 2002-08-21 |
| VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326) | bioMerieux, Inc. | 2002-07-18 |
| TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (K014120) | Diagnostics Biochem Canada, Inc. | 2002-02-08 |
| BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (K002294) | Biocheck, Inc. | 2000-10-02 |
| ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 (K001935) | Beckman Coulter, Inc. | 2000-08-22 |
| FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (K001086) | Diagnostic Systems Laboratories, Inc. | 2000-05-18 |
| DRG AURICA ELISA TESTOSTERONE KIT (K000043) | Drg Intl., Inc. | 2000-04-17 |
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |
| TESTOTERONE ELISA (K973900) | Kmi Diagnostics, Inc. | 1998-02-24 |
| ACTIVE TESTOSTERONE EIA (DSL-10-4000) (K971823) | Diagnostic Systems Laboratories, Inc. | 1997-06-16 |
| ELECSYS TESTOSTERONE ASSAY (K964889) | Boehringer Mannheim Corp. | 1997-03-18 |
| TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080) | Bayer Corp. | 1996-09-27 |
| BIODATA TESTOSTERONE MAIA KIT (K955102) | Biochem Immunosystems (U.S.), Inc. | 1996-06-24 |
| IMMULITE TOTAL TESTOSTERONE (K955870) | Diagnostic Products Corp. | 1996-02-06 |
| IMMULITE SHBG (MODIFICATION) (K955440) | Diagnostic Products Corp. | 1995-12-21 |
| AURAFLEX TESTOSTERONE CALIBRATOR PACK (K951685) | Organon Teknika Corp. | 1995-11-14 |
| ACTIVE FREE TESTOSTERONE RIA (K952281) | Diagnostic Systems Laboratories, Inc. | 1995-07-17 |
| IMMULITE SHBG (K941797) | Diagnostic Products Corp. | 1994-10-31 |
| DELFIA SHBG KIT (K940449) | Wallac OY | 1994-09-06 |
| CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY (K934562) | Ciba Corning Diagnostics Corp. | 1993-12-10 |
| DELFIA TESTTOSTERONE KIT (K932951) | Wallac OY | 1993-08-03 |
| TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (K924257) | Serono-Baker Diagnostics, Inc. | 1992-11-30 |
| DSL ACTIVE SHBG (DSL 7400) (K915823) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 |
| SRI TESTOSTERONE ENZYME IMMUNOASSAY (K915164) | Serono-Baker Diagnostics, Inc. | 1992-03-02 |
| GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT (K915570) | Incstar Corp. | 1992-01-27 |
| SHBG (K912850) | Wien Laboratories, Inc. | 1991-08-12 |
| SHBG IRMA KIT (K905247) | Ventrex Laboratories, Inc. | 1991-01-17 |
| DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) (K904100) | Diagnostic Systems Laboratories, Inc. | 1990-10-15 |
| DELFIA SHBG KIT (K884809) | Pharmacia, Inc. | 1989-03-08 |
| IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) (K883267) | Diagnostic Products Corp. | 1988-10-31 |
| SHBG IRMA KIT (K861679) | Farmos Group , Ltd. | 1987-03-13 |
| PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (K862483) | Pantex, Div. Bio-Analysis, Inc. | 1987-01-14 |
| LEECO TESTOSTERONE DIAGNOSTIC KIT (K860003) | Leeco Diagnostics, Inc. | 1986-03-17 |
| TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT (K860130) | Cambridge Medical Technology | 1986-02-19 |
| DSL ACTIVE TESTOSTERONE RIA (DSL #4000) (K854671) | Diagnostic Systems Laboratories, Inc. | 1985-12-19 |
| DSL ANDROSTENDIONE RIA (DSL #4200) (K854674) | Diagnostic Systems Laboratories, Inc. | 1985-12-19 |
| PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO (K853865) | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 |
| COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS (K844423) | Diagnostic Products Corp. | 1985-02-27 |
| TESTOSTERONE DIRECT RADIOIMMUNOASSAY (K841948) | Sorin Biomedica, Fiat, USA, Inc. | 1984-06-25 |
| MATCHED COMPONENT SET RADIOIMMUNOASSAY (K841042) | Cambridge Medical Technology | 1984-04-19 |
| IMMOPHASE DTESTO RADIOIMMUNOASSAY- (K840187) | Corning Medical & Scientific | 1984-03-23 |
| COAT-A-COUNT NO-EXTRACTION TESTOSTERONE (K831342) | Diagnostic Products Corp. | 1983-06-02 |
| LEECO TESTOSTERONE DIAGNOSTIC KIT (K830512) | Leeco Diagnostics, Inc. | 1983-04-05 |
| COAT-A-COUNT TESTOSTERONE RIA KIT (K813401) | Diagnostic Products Corp. | 1981-12-22 |
| LEECO TESTO-QUANT DIAG. KIT (K813059) | Leeco Diagnostics, Inc. | 1981-11-16 |
| DIRECT TESTOSTERONE RIA (K811536) | Immuchem Corp. | 1981-06-18 |
| LEECO TESTO-QUANT DIAGNOSTIC KIT (K803001) | Leeco Diagnostics, Inc. | 1981-01-02 |
| 125I-TESTOSTERONE TEST SET (K802728) | Wien Laboratories, Inc. | 1980-12-11 |
| LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (K802661) | Damon Corp. | 1980-12-10 |
| TESTOSTERONE RADIOIMMUNOASSY KIT (K802135) | Radioimmunoassay, Inc. | 1980-10-10 |
| TESTOSTERONE KIT (K801666) | Immuchem Corp. | 1980-08-27 |
| NORDICLAB TESTOSTERONE RIA TEST (K800921) | Nordiclab Intl. | 1980-05-14 |
| TESTOK-125 (K800776) | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 |
| (125I) TESTOSTERONE KIT (K791999) | Radioassay Systems Laboratories, Inc. | 1979-10-30 |
| I TESTOTERONE (K790007) | Cambridge Nuclear Corp. | 1979-02-26 |
| TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (K780792) | The Upjohn Co. | 1978-06-13 |
| TESTOSTERONE RIA KIT (125I) (K772191) | Diagnostic Products Corp. | 1978-01-12 |