FDA Product Code
FDA Product Code CDZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1680
510(k) Clearances — 89 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026-04-15 | Traditional | PDF ↗ |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024-10-23 | Traditional | PDF ↗ |
| K233480 | Access SHBG | Beckman Coulter, Inc. | 2024-02-08 | Traditional | PDF ↗ |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | 2023-01-13 | Traditional | PDF ↗ |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022-05-06 | Traditional | PDF ↗ |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | 2020-10-15 | Special | PDF ↗ |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | 2019-12-20 | Special | PDF ↗ |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 | Traditional | PDF ↗ |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 | Traditional | PDF ↗ |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019-01-29 | Traditional | PDF ↗ |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018-07-20 | Traditional | PDF ↗ |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | 2016-02-11 | Traditional | PDF ↗ |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 | Traditional | PDF ↗ |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | 2015-12-17 | Traditional | PDF ↗ |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015-07-02 | Traditional | PDF ↗ |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Siemens Healthcare Diagnostics, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | DiaSorin, Inc. | 2013-01-25 | Traditional | PDF ↗ |
| K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) | Abbott Laboratories | 2012-09-11 | Traditional | PDF ↗ |
| K101388 | FASTPACK TESTO IMMUNOASSAY | Qualigen, Inc. | 2011-02-18 | Special | PDF ↗ |
| K102814 | ELECYSYS SHBG | Roche Diagnostics | 2011-01-20 | Traditional | PDF ↗ |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Roche Diagnostics Corp. | 2010-04-23 | Traditional | PDF ↗ |
| K091867 | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 | Siemens Healthcare Diagnostics | 2010-01-14 | Traditional | PDF ↗ |
| K083867 | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND | Beckman Coulter, Inc. | 2009-08-27 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K052649 | DRG SLV TESTOSTERONE ELISA TEST | Drg Intl., Inc. | 2006-01-27 | Traditional | PDF ↗ |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 | Traditional | PDF ↗ |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Diagnostic Products Corp. | 2003-10-10 | Special | PDF ↗ |
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Diagnostics Biochem Canada, Inc. | 2003-08-18 | Traditional | PDF ↗ |
| K031717 | ELECSYS SHBG IMMUNOASSAY | Roche Diagnostics Corp. | 2003-08-05 | Traditional | PDF ↗ |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Tosoh Medics, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY | Qualigen, Inc. | 2002-08-21 | Traditional | PDF ↗ |
| K021326 | VIDAS TESTOSTERONE (TES), MODEL 30 418 | bioMerieux, Inc. | 2002-07-18 | Traditional | PDF ↗ |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | Diagnostics Biochem Canada, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | Biocheck, Inc. | 2000-10-02 | Traditional | PDF ↗ |
| K001935 | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 | Beckman Coulter, Inc. | 2000-08-22 | Traditional | PDF ↗ |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | Diagnostic Systems Laboratories, Inc. | 2000-05-18 | Traditional | PDF ↗ |
| K000043 | DRG AURICA ELISA TESTOSTERONE KIT | Drg Intl., Inc. | 2000-04-17 | Traditional | PDF ↗ |
| K983212 | ABBOTT ARCHITECT TESTOSTERONE | Abbott Laboratories | 1998-11-18 | Traditional | PDF ↗ |
| K973900 | TESTOTERONE ELISA | Kmi Diagnostics, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | Diagnostic Systems Laboratories, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K964889 | ELECSYS TESTOSTERONE ASSAY | Boehringer Mannheim Corp. | 1997-03-18 | Traditional | PDF ↗ |
| K963080 | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-09-27 | Traditional | PDF ↗ |
| K955102 | BIODATA TESTOSTERONE MAIA KIT | Biochem Immunosystems (U.S.), Inc. | 1996-06-24 | Traditional | PDF ↗ |
| K955870 | IMMULITE TOTAL TESTOSTERONE | Diagnostic Products Corp. | 1996-02-06 | Traditional | PDF ↗ |
| K955440 | IMMULITE SHBG (MODIFICATION) | Diagnostic Products Corp. | 1995-12-21 | Traditional | PDF ↗ |
| K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK | Organon Teknika Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K952281 | ACTIVE FREE TESTOSTERONE RIA | Diagnostic Systems Laboratories, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K941797 | IMMULITE SHBG | Diagnostic Products Corp. | 1994-10-31 | Traditional | PDF ↗ |
| K940449 | DELFIA SHBG KIT | Wallac OY | 1994-09-06 | Traditional | PDF ↗ |
| K934562 | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-10 | Traditional | PDF ↗ |
| K932951 | DELFIA TESTTOSTERONE KIT | Wallac OY | 1993-08-03 | Traditional | PDF ↗ |
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K915823 | DSL ACTIVE SHBG (DSL 7400) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K915570 | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT | Incstar Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K912850 | SHBG | Wien Laboratories, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K905247 | SHBG IRMA KIT | Ventrex Laboratories, Inc. | 1991-01-17 | Traditional | PDF ↗ |
| K904100 | DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) | Diagnostic Systems Laboratories, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K884809 | DELFIA SHBG KIT | Pharmacia, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K883267 | IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) | Diagnostic Products Corp. | 1988-10-31 | Traditional | PDF ↗ |
| K861679 | SHBG IRMA KIT | Farmos Group , Ltd. | 1987-03-13 | Traditional | PDF ↗ |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1987-01-14 | Traditional | PDF ↗ |
| K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | 1986-02-19 | Traditional | PDF ↗ |
| K854674 | DSL ANDROSTENDIONE RIA (DSL #4200) | Diagnostic Systems Laboratories, Inc. | 1985-12-19 | Traditional | PDF ↗ |
| K854671 | DSL ACTIVE TESTOSTERONE RIA (DSL #4000) | Diagnostic Systems Laboratories, Inc. | 1985-12-19 | Traditional | PDF ↗ |
| K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 | Traditional | PDF ↗ |
| K844423 | COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS | Diagnostic Products Corp. | 1985-02-27 | Traditional | PDF ↗ |
| K841948 | TESTOSTERONE DIRECT RADIOIMMUNOASSAY | Sorin Biomedica, Fiat, USA, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY | Cambridge Medical Technology | 1984-04-19 | Traditional | PDF ↗ |
| K840187 | IMMOPHASE DTESTO RADIOIMMUNOASSAY- | Corning Medical & Scientific | 1984-03-23 | Traditional | PDF ↗ |
| K831342 | COAT-A-COUNT NO-EXTRACTION TESTOSTERONE | Diagnostic Products Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K813401 | COAT-A-COUNT TESTOSTERONE RIA KIT | Diagnostic Products Corp. | 1981-12-22 | Traditional | PDF ↗ |
| K813059 | LEECO TESTO-QUANT DIAG. KIT | Leeco Diagnostics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K811536 | DIRECT TESTOSTERONE RIA | Immuchem Corp. | 1981-06-18 | Traditional | PDF ↗ |
| K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K802728 | 125I-TESTOSTERONE TEST SET | Wien Laboratories, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT | Damon Corp. | 1980-12-10 | Traditional | PDF ↗ |
| K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT | Radioimmunoassay, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801666 | TESTOSTERONE KIT | Immuchem Corp. | 1980-08-27 | Traditional | PDF ↗ |
| K800921 | NORDICLAB TESTOSTERONE RIA TEST | Nordiclab Intl. | 1980-05-14 | Traditional | PDF ↗ |
| K800776 | TESTOK-125 | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K791999 | (125I) TESTOSTERONE KIT | Radioassay Systems Laboratories, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K790007 | I TESTOTERONE | Cambridge Nuclear Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K780792 | TESTOSTERONE RADIOIMMUNOASSAY KIT 125I | The Upjohn Co. | 1978-06-13 | Traditional | PDF ↗ |
| K772191 | TESTOSTERONE RIA KIT (125I) | Diagnostic Products Corp. | 1978-01-12 | Traditional | PDF ↗ |
Product code CDZ · Class I · Clinical Chemistry. Data: openFDA.