Panels › Clinical Chemistry › Product code CDZ · Class 1
Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation 862.1680
1510(k)s in 12 months (89 all time)
2recalls in 12 months (19 all time)
17recalls that name a 510(k)
Top companies in CDZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2026 | K252728 | IDS-iSYS Total Testosterone Immunodiagnostic Systems Limited, GB | CDZ |
| Oct 23, 2024 | K240865 | IDS-iSYS Free Testosterone Immunodiagnostic Systems Limited, GB | CDZ |
| Feb 8, 2024 | K233480 | Access SHBG Beckman Coulter, Inc. | CDZ |
| Jan 13, 2023 | K223405 | Access Testosterone Beckman Coulter, Inc. | CDZ |
| May 6, 2022 | K211685 | Elecsys Testosterone II Roche Diagnostics | CDZ |
| Oct 15, 2020 | K201908 | LIAISON Testosterone xt DiaSorin, Inc. | CDZ |
| Dec 20, 2019 | K191350 | ACTIVE® Free Testosterone RIA Immunotech S.R.O., CZ | CDZ |
| Aug 28, 2019 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG Siemens Healthcare Diagnostics, Inc. | CDZ |
| Jun 17, 2019 | K190121 | IDS SHBG Immunodiagnostic Systems , Ltd., GB | CDZ |
| Jan 29, 2019 | K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc. | CDZ |
| Jul 20, 2018 | K181017 | Free Testosterone AccuBind ELISA Test System Monobind, Inc. | CDZ |
| Oct 14, 2016 | K153577 | FREND Testosterone Test System Nanoentek USA, Inc. | CDZ |
| Jun 29, 2016 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, AD Siemens Healthcare Diagnostics, Inc. | CDZ |
| Feb 11, 2016 | K152185 | ARCHITECT SHBG Biokit, S.A., ES | CDZ |
| Feb 11, 2016 | K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator Siemens Healthcare Diagnostics, Inc. | CDZ |
| Dec 17, 2015 | K152155 | ARCHITECT 2nd Generation Testosterone Abbott Laboratories | CDZ |
| Jul 2, 2015 | K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set Tosoh Bioscience, Inc. | CDZ |
| Feb 21, 2014 | K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) Siemens Healthcare Diagnostics, Inc. | CDZ |
| Jan 25, 2013 | K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DiaSorin, Inc. | CDZ |
| Sep 11, 2012 | K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) Abbott Laboratories | CDZ |
| Feb 18, 2011 | K101388 | FASTPACK TESTO IMMUNOASSAY Qualigen, Inc. | CDZ |
| Jan 20, 2011 | K102814 | ELECYSYS SHBG Roche Diagnostics | CDZ |
| Apr 23, 2010 | K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY Roche Diagnostics Corp. | CDZ |
| Jan 14, 2010 | K091867 | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 Siemens Healthcare Diagnostics | CDZ |
| Aug 27, 2009 | K083867 | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND Beckman Coulter, Inc. | CDZ |
| Jan 23, 2007 | K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 Biokit, S.A., ES | CDZ |
| Jan 27, 2006 | K052649 | DRG SLV TESTOSTERONE ELISA TEST Drg Intl., Inc. | CDZ |
| Sep 29, 2004 | K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) Axis-Shield Diagnostics, Ltd., GB | CDZ |
| Oct 10, 2003 | K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE Diagnostic Products Corp. | CDZ |
| Aug 18, 2003 | K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT Diagnostics Biochem Canada, Inc., CA | CDZ |
| Aug 5, 2003 | K031717 | ELECSYS SHBG IMMUNOASSAY Roche Diagnostics Corp. | CDZ |
| Dec 17, 2002 | K023091 | ST AIA-PACK TESTOSTERONE ASSAY Tosoh Medics, Inc. | CDZ |
| Aug 21, 2002 | K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY Qualigen, Inc. | CDZ |
| Jul 18, 2002 | K021326 | VIDAS TESTOSTERONE (TES), MODEL 30 418 bioMerieux, Inc. | CDZ |
| Feb 8, 2002 | K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) Diagnostics Biochem Canada, Inc., CA | CDZ |
| Oct 2, 2000 | K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 Biocheck, Inc. | CDZ |
| Aug 22, 2000 | K001935 | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 Beckman Coulter, Inc. | CDZ |
| May 18, 2000 | K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 Diagnostic Systems Laboratories, Inc. | CDZ |
| Apr 17, 2000 | K000043 | DRG AURICA ELISA TESTOSTERONE KIT Drg Intl., Inc. | CDZ |
| Nov 18, 1998 | K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories | CDZ |
| Feb 24, 1998 | K973900 | TESTOTERONE ELISA Kmi Diagnostics, Inc. | CDZ |
| Jun 16, 1997 | K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) Diagnostic Systems Laboratories, Inc. | CDZ |
| Mar 18, 1997 | K964889 | ELECSYS TESTOSTERONE ASSAY Boehringer Mannheim Corp. | CDZ |
| Sep 27, 1996 | K963080 | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | CDZ |
| Jun 24, 1996 | K955102 | BIODATA TESTOSTERONE MAIA KIT Biochem Immunosystems (U.S.), Inc. | CDZ |
| Feb 6, 1996 | K955870 | IMMULITE TOTAL TESTOSTERONE Diagnostic Products Corp. | CDZ |
| Dec 21, 1995 | K955440 | IMMULITE SHBG (MODIFICATION) Diagnostic Products Corp. | CDZ |
| Nov 14, 1995 | K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK Organon Teknika Corp. | CDZ |
| Jul 17, 1995 | K952281 | ACTIVE FREE TESTOSTERONE RIA Diagnostic Systems Laboratories, Inc. | CDZ |
| Oct 31, 1994 | K941797 | IMMULITE SHBG Diagnostic Products Corp. | CDZ |
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