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 Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326
bioMerieux, Inc.
Chemistry · 83d
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 Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212
Abbott Laboratories
Chemistry · 65d
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 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
Cleared Jul 17, 1995
ACTIVE FREE TESTOSTERONE RIA
K952281
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Oct 31, 1994
IMMULITE SHBG
K941797
Diagnostic Products Corp.
Chemistry · 202d
Cleared Dec 10, 1993
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Mar 17, 1992
DSL ACTIVE SHBG (DSL 7400)
K915823
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Jan 27, 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570
Incstar Corp.
Chemistry · 46d
Cleared Jan 17, 1991
SHBG IRMA KIT
K905247
Ventrex Laboratories, Inc.
Chemistry · 57d
Cleared Oct 15, 1990
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100
Diagnostic Systems Laboratories, Inc.
Chemistry · 39d
Cleared Mar 08, 1989
DELFIA SHBG KIT
K884809
Pharmacia, Inc.
Chemistry · 111d
Cleared Oct 31, 1988
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)
K883267
Diagnostic Products Corp.
Chemistry · 89d
Cleared Mar 17, 1986
LEECO TESTOSTERONE DIAGNOSTIC KIT
K860003
Leeco Diagnostics, Inc.
Chemistry · 74d
Cleared Dec 19, 1985
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
DSL ANDROSTENDIONE RIA (DSL #4200)
K854674
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Feb 27, 1985
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423
Diagnostic Products Corp.
Chemistry · 104d
Cleared Mar 23, 1984
IMMOPHASE DTESTO RADIOIMMUNOASSAY-
K840187
Corning Medical & Scientific
Chemistry · 65d