CDZ · Class I · 21 CFR 862.1680

FDA Product Code CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

FDA product code CDZ covers radioimmunoassay systems for the measurement of testosterone and dihydrotestosterone in serum.

These assays quantify androgens involved in male sexual development, reproductive function, and secondary sex characteristics. Testosterone measurement is used in the diagnosis of hypogonadism, polycystic ovary syndrome, and monitoring of androgen replacement therapy.

CDZ devices are Class I medical devices, regulated under 21 CFR 862.1680 and reviewed by the FDA Immunology panel.

Leading manufacturers include Diagnostic Products Corp., Diagnostic Systems Laboratories, Inc. and Siemens Healthcare Diagnostics, Inc..

89
Total
89
Cleared
109d
Avg days
1978
Since
89 devices
25–48 of 89
Cleared Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867
Beckman Coulter, Inc.
Chemistry · 241d
Cleared Jan 23, 2007
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
K060818
Biokit, S.A.
Chemistry · 302d
Cleared Jan 27, 2006
DRG SLV TESTOSTERONE ELISA TEST
K052649
Drg Intl., Inc.
Chemistry · 123d
Cleared Sep 29, 2004
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866
Axis-Shield Diagnostics, Ltd.
Chemistry · 82d
Cleared Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881
Diagnostic Products Corp.
Chemistry · 25d
Cleared Aug 18, 2003
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
K030730
Diagnostics Biochem Canada, Inc.
Chemistry · 161d
Cleared Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
K031717
Roche Diagnostics Corp.
Chemistry · 63d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Aug 21, 2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
K021972
Qualigen, Inc.
Chemistry · 65d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326
bioMerieux, Inc.
Chemistry · 83d
Cleared Feb 08, 2002
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
K014120
Diagnostics Biochem Canada, Inc.
Chemistry · 53d
Cleared Oct 02, 2000
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294
Biocheck, Inc.
Chemistry · 67d
Cleared Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
K001935
Beckman Coulter, Inc.
Chemistry · 57d
Cleared May 18, 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086
Diagnostic Systems Laboratories, Inc.
Immunology · 44d
Cleared Apr 17, 2000
DRG AURICA ELISA TESTOSTERONE KIT
K000043
Drg Intl., Inc.
Chemistry · 102d
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212
Abbott Laboratories
Chemistry · 65d
Cleared Feb 24, 1998
TESTOTERONE ELISA
K973900
Kmi Diagnostics, Inc.
Chemistry · 133d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
K964889
Boehringer Mannheim Corp.
Chemistry · 102d
Cleared Sep 27, 1996
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K963080
Bayer Corp.
Chemistry · 50d
Cleared Jun 24, 1996
BIODATA TESTOSTERONE MAIA KIT
K955102
Biochem Immunosystems (U.S.), Inc.
Chemistry · 229d
Cleared Feb 06, 1996
IMMULITE TOTAL TESTOSTERONE
K955870
Diagnostic Products Corp.
Chemistry · 40d
Cleared Dec 21, 1995
IMMULITE SHBG (MODIFICATION)
K955440
Diagnostic Products Corp.
Chemistry · 59d
Cleared Nov 14, 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685
Organon Teknika Corp.
Chemistry · 218d