Transferrin, Antigen, Antiserum, Control

FDA product code DDG · 48 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5880
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-12-22 – 2024-07-03

DDG 2024-07-03

Access sTfR

Applicant Beckman Coulter, Inc.

K number K240987

View details →

DDG 2020-03-16

Transferrin

Applicant Biosystems S.A.

K number K190495

View details →

DDG 2018-11-05

Tina-quant Transferrin ver.2 (urine application)

Applicant Roche Diagnostics Operations (Rdo)

K number K182095

View details →

DDG 2013-02-13

TRANSFERRIN KIT FOR USE ON THE SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K120236

View details →

DDG 2008-08-11

ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495

Applicant Beckman Coulter, Inc.

K number K080634

View details →

DDG 2008-08-08

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

Applicant Siemens Healthcare Diagnostics, Inc.

K number K081299

View details →

DDG 2007-08-08

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

Applicant Thermo Electron OY

K number K063086

View details →

DDG 2007-04-23

TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C

Applicant Good Biotech Corp.

K number K063766

View details →

DDG 2007-03-21

DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H

Applicant Dade Behring, Inc.

K number K063663

View details →

DDG 2007-01-24

DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H

Applicant Dade Behring, Inc.

K number K063322

View details →

DDG 2006-03-16

N ANTISERA TO HUMAN TRANSFERRIN

Applicant Dade Behring, Inc.

K number K053075

View details →

DDG 2004-11-19

VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042477

View details →

DDG 2001-09-19

TINA-QUANT TRANSFERRIN VER.2

Applicant Roche Diagnostics Corp.

K number K012393

View details →

DDG 2001-09-19

TINA-QUANT TRANSFERRIN VER.2

Applicant Roche Diagnostics Corp.

K number K012371

View details →

DDG 2001-07-30

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

Applicant The Binding Site, Ltd.

K number K011662

View details →

DDG 2001-05-01

TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

Applicant Roche Diagnostics Corp.

K number K003064

View details →

DDG 2001-02-05

RANDOX TRANSFERRIN

Applicant Randox Laboratories, Ltd.

K number K002585

View details →

DDG 2000-02-04

DIMENSION TRNF FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K994294

View details →

DDG 1999-11-30

K-ASSAY TRANSFERRIN

Applicant Kamiya Biomedical Co.

K number K993537

View details →

DDG 1999-11-12

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

Applicant Wako Chemicals USA, Inc.

K number K993162

View details →

DDG 1999-08-02

N LATEX STFR REAGENT

Applicant Dade Behring, Inc.

K number K991157

View details →

DDG 1998-12-18

TRANSFERRIN SPQ III ANTIBODY REAGENT SET

Applicant DiaSorin, Inc.

K number K983880

View details →

DDG 1998-11-04

TRF

Applicant Abbott Laboratories

K number K983167

View details →

DDG 1997-10-17

N ANTISERUM TO HUMAN TRANSFERRIN

Applicant Behring Diagnostics, Inc.

K number K972840

View details →

DDG 1997-08-20

SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT

Applicant Beckman Instruments, Inc.

K number K971958

View details →

DDG 1997-06-16

N-ASSAY TIA TRANSFERRIN TEST KIT

Applicant Crestat Diagnostics, Inc.

K number K964295

View details →

DDG 1997-03-19

IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT

Applicant Beckman Instruments, Inc.

K number K963976

View details →

DDG 1996-10-07

IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT

Applicant Beckman Instruments, Inc.

K number K963427

View details →

DDG 1993-11-03

BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY

Applicant Boehringer Mannheim Corp.

K number K933589

View details →

DDG 1993-10-07

BECKMAN TRANSFERRIN KIT

Applicant Beckman Instruments, Inc.

K number K926272

View details →

DDG 1992-01-17

IL TEST(TM) TRANSFERRIN (TRF)

Applicant Instrumentation Laboratory CO

K number K914993

View details →

DDG 1991-12-09

TRANSFERRIN RID KIT

Applicant The Binding Site, Ltd.

K number K914390

View details →

DDG 1990-03-06

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT

Applicant Reagents Applications, Inc.

K number K900875

View details →

DDG 1989-03-03

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF

Applicant Atlantic Antibodies

K number K890563

View details →

DDG 1988-10-19

IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN

Applicant Orion Diagnostica, Inc.

K number K884075

View details →

DDG 1987-10-13

TRANSFERRIN

Applicant Unipath , Ltd.

K number K873867

View details →

DDG 1987-10-07

QM300 TRANSFERRIN ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K873789

View details →

DDG 1987-06-15

TINA-QUANT [A] TRANSFERRIN

Applicant Boehringer Mannheim Corp.

K number K871896

View details →

DDG 1987-05-14

PRECIMAT(R) TRANSFERRIN

Applicant Boehringer Mannheim Corp.

K number K871022

View details →

DDG 1986-02-21

TDX TRANSFERRIN DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K854416

View details →

DDG 1985-05-24

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN

Applicant Cooper Biomedical, Inc.

K number K851287

View details →

DDG 1985-03-05

SPQ TEST SYSTEM FOR TRANSFERRIN

Applicant Applications Lab

K number K850589

View details →

DDG 1983-06-10

RADIAL IMMUNODIFFUSION PLATES

Applicant Biocell Laboratories, Inc.

K number K830911

View details →

DDG 1981-12-17

NEIA TRANSFERRIN ENZYMEIMMUNOASSAY

Applicant New England Immunology Assoc.

K number K813288

View details →

DDG 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN

Applicant Dako Corp.

K number K812492

View details →

DDG 1981-08-12

72 DETERMIN. SIZE RADIAL IMMUNOD. TEST

Applicant Kent Laboratories, Inc.

K number K811613

View details →

DDG 1980-07-08

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS

Applicant J.T. Baker Chemical Co.

K number K801434

View details →

DDG 1977-12-22

TRANSFERRIN NEPHELOMETRIC ASSAY

Applicant Kallestad Laboratories, Inc.

K number K772253

View details →