Radioimmunoassay, Testosterones And Dihydrotestosterone

CDZ 2024-10-23

IDS-iSYS Free Testosterone

Applicant Immunodiagnostic Systems Limited

K number K240865

CDZ 2024-02-08

Access SHBG

Applicant Beckman Coulter, Inc.

K number K233480

CDZ 2023-01-13

Access Testosterone

Applicant Beckman Coulter, Inc.

K number K223405

CDZ 2022-05-06

Elecsys Testosterone II

Applicant Roche Diagnostics

K number K211685

CDZ 2020-10-15

LIAISON Testosterone xt

Applicant DiaSorin, Inc.

K number K201908

CDZ 2019-12-20

ACTIVE® Free Testosterone RIA

Applicant Immunotech S.R.O.

K number K191350

CDZ 2019-08-28

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

Applicant Siemens Healthcare Diagnostics, Inc.

K number K191533

CDZ 2019-06-17

IDS SHBG

Applicant Immunodiagnostic Systems , Ltd.

K number K190121

CDZ 2019-01-29

FastPack IP Sex Hormone Binding Globulin Immunoassay

Applicant Qualigen, Inc.

K number K182521

CDZ 2018-07-20

Free Testosterone AccuBind ELISA Test System

Applicant Monobind, Inc.

K number K181017

CDZ 2016-10-14

FREND Testosterone Test System

Applicant Nanoentek USA, Inc.

K number K153577

CDZ 2016-06-29

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

Applicant Siemens Healthcare Diagnostics, Inc.

K number K151986

CDZ 2016-02-11

ARCHITECT SHBG

Applicant Biokit, S.A.

K number K152185

CDZ 2016-02-11

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

Applicant Siemens Healthcare Diagnostics, Inc.

K number K151529

CDZ 2013-01-25

LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET

Applicant DiaSorin, Inc.

K number K122793

CDZ 2012-09-11

TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)

Applicant Abbott Laboratories

K number K120009

CDZ 2011-02-18

FASTPACK TESTO IMMUNOASSAY

Applicant Qualigen, Inc.

K number K101388

CDZ 2011-01-20

ELECYSYS SHBG

Applicant Roche Diagnostics

K number K102814

CDZ 2010-04-23

ELECSYS TESTOSTERONE II IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K093421

CDZ 2010-01-14

ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773

Applicant Siemens Healthcare Diagnostics

K number K091867

CDZ 2009-08-27

ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND

Applicant Beckman Coulter, Inc.

K number K083867

CDZ 2007-01-23

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

Applicant Biokit, S.A.

K number K060818

CDZ 2006-01-27

DRG SLV TESTOSTERONE ELISA TEST

Applicant Drg Intl., Inc.

K number K052649

CDZ 2004-09-29

ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

Applicant Axis-Shield Diagnostics, Ltd.

K number K041866

CDZ 2003-10-10

IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

K number K032881

CDZ 2003-08-18

FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT

Applicant Diagnostics Biochem Canada, Inc.

K number K030730

CDZ 2003-08-05

ELECSYS SHBG IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K031717

CDZ 2002-12-17

ST AIA-PACK TESTOSTERONE ASSAY

Applicant Tosoh Medics, Inc.

K number K023091

CDZ 2002-08-21

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

Applicant Qualigen, Inc.

K number K021972

CDZ 2002-07-18

VIDAS TESTOSTERONE (TES), MODEL 30 418

Applicant bioMerieux, Inc.

K number K021326

CDZ 2002-02-08

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)

Applicant Diagnostics Biochem Canada, Inc.

K number K014120

CDZ 2000-10-02

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

Applicant Biocheck, Inc.

K number K002294

CDZ 2000-08-22

ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

Applicant Beckman Coulter, Inc.

K number K001935

CDZ 2000-05-18

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900

K number K001086

CDZ 2000-04-17

DRG AURICA ELISA TESTOSTERONE KIT

Applicant Drg Intl., Inc.

K number K000043

CDZ 1998-11-18

ABBOTT ARCHITECT TESTOSTERONE

Applicant Abbott Laboratories

K number K983212

CDZ 1998-02-24

TESTOTERONE ELISA

Applicant Kmi Diagnostics, Inc.

K number K973900

CDZ 1997-06-16

ACTIVE TESTOSTERONE EIA (DSL-10-4000)

K number K971823

CDZ 1997-03-18

ELECSYS TESTOSTERONE ASSAY

Applicant Boehringer Mannheim Corp.

K number K964889

CDZ 1996-09-27

TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K963080

CDZ 1996-06-24

BIODATA TESTOSTERONE MAIA KIT

Applicant Biochem Immunosystems (U.S.), Inc.

K number K955102

CDZ 1996-02-06

IMMULITE TOTAL TESTOSTERONE

K number K955870

CDZ 1995-12-21

IMMULITE SHBG (MODIFICATION)

K number K955440

CDZ 1995-11-14

AURAFLEX TESTOSTERONE CALIBRATOR PACK

Applicant Organon Teknika Corp.

K number K951685

CDZ 1995-07-17

ACTIVE FREE TESTOSTERONE RIA

K number K952281

CDZ 1994-10-31

IMMULITE SHBG

K number K941797

CDZ 1994-09-06

DELFIA SHBG KIT

Applicant Wallac OY

K number K940449

CDZ 1993-12-10

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K934562

CDZ 1993-08-03

DELFIA TESTTOSTERONE KIT

Applicant Wallac OY

K number K932951

CDZ 1992-11-30

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K924257

CDZ 1992-03-17

DSL ACTIVE SHBG (DSL 7400)

K number K915823

CDZ 1992-03-02

SRI TESTOSTERONE ENZYME IMMUNOASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K915164

CDZ 1992-01-27

GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT

Applicant Incstar Corp.

K number K915570

CDZ 1991-08-12

SHBG

Applicant Wien Laboratories, Inc.

K number K912850

CDZ 1991-01-17

SHBG IRMA KIT

Applicant Ventrex Laboratories, Inc.

K number K905247

CDZ 1990-10-15

DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)

K number K904100

CDZ 1989-03-08

DELFIA SHBG KIT

Applicant Pharmacia, Inc.

K number K884809

CDZ 1988-10-31

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)

K number K883267

CDZ 1987-03-13

SHBG IRMA KIT

Applicant Farmos Group , Ltd.

K number K861679

CDZ 1987-01-14

PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K862483

CDZ 1986-03-17

LEECO TESTOSTERONE DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K860003

CDZ 1986-02-19

TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT

Applicant Cambridge Medical Technology

K number K860130

CDZ 1985-12-19

DSL ANDROSTENDIONE RIA (DSL #4200)

K number K854674

CDZ 1985-12-19

DSL ACTIVE TESTOSTERONE RIA (DSL #4000)

K number K854671

CDZ 1985-10-15

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K853865

CDZ 1985-02-27

COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS

K number K844423

CDZ 1984-06-25

TESTOSTERONE DIRECT RADIOIMMUNOASSAY

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K841948

CDZ 1984-04-19

MATCHED COMPONENT SET RADIOIMMUNOASSAY

Applicant Cambridge Medical Technology

K number K841042

CDZ 1984-03-23

IMMOPHASE DTESTO RADIOIMMUNOASSAY-

Applicant Corning Medical & Scientific

K number K840187

CDZ 1983-06-02

COAT-A-COUNT NO-EXTRACTION TESTOSTERONE

K number K831342

CDZ 1983-04-05

LEECO TESTOSTERONE DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K830512

CDZ 1981-12-22

COAT-A-COUNT TESTOSTERONE RIA KIT

K number K813401

CDZ 1981-11-16

LEECO TESTO-QUANT DIAG. KIT

Applicant Leeco Diagnostics, Inc.

K number K813059

CDZ 1981-06-18

DIRECT TESTOSTERONE RIA

Applicant Immuchem Corp.

K number K811536

CDZ 1981-01-02

LEECO TESTO-QUANT DIAGNOSTIC KIT

Applicant Leeco Diagnostics, Inc.

K number K803001

CDZ 1980-12-11

125I-TESTOSTERONE TEST SET

Applicant Wien Laboratories, Inc.

K number K802728

CDZ 1980-12-10

LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT

Applicant Damon Corp.

K number K802661

CDZ 1980-10-10

TESTOSTERONE RADIOIMMUNOASSY KIT

Applicant Radioimmunoassay, Inc.

K number K802135

CDZ 1980-08-27

TESTOSTERONE KIT

Applicant Immuchem Corp.

K number K801666

CDZ 1980-05-14

NORDICLAB TESTOSTERONE RIA TEST

Applicant Nordiclab Intl.

K number K800921

CDZ 1980-04-21

TESTOK-125

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K800776

CDZ 1979-10-30

(125I) TESTOSTERONE KIT

Applicant Radioassay Systems Laboratories, Inc.

K number K791999

CDZ 1979-02-26

I TESTOTERONE

Applicant Cambridge Nuclear Corp.

K number K790007

CDZ 1978-06-13

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I

Applicant The Upjohn Co.

K number K780792

CDZ 1978-01-12

TESTOSTERONE RIA KIT (125I)

K number K772191