Ferritin, Antigen, Antiserum, Control

FDA product code DBF · 86 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5340
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-17 – 2021-09-14

DBF 2021-09-14

LIAISON Ferritin

Applicant DiaSorin, Inc.

K number K193650

View details →

DBF 2020-03-06

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

Applicant HORIBA ABX SAS

K number K191562

View details →

DBF 2017-08-31

Atellica IM Ferritin Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K171642

View details →

DBF 2012-05-24

K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR

Applicant Kamiya Biomedical Company

K number K121232

View details →

DBF 2011-08-17

ADVIA CHEMISTRY FERRITIN (FRT) METHOD

Applicant Siemens Healthcare Diagnostics, Inc.

K number K110736

View details →

DBF 2010-06-22

TINA-QUANT FERRITIN GEN. 4

Applicant Roche Diagnostics

K number K100538

View details →

DBF 2009-12-11

BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203

Applicant Beckman Coulter, Inc.

K number K092505

View details →

DBF 2006-11-20

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

Applicant Medicon Hellas S.A

K number K062746

View details →

DBF 2006-03-13

RDI HSFERRITIN KIT

Applicant Reference Diagnostics, Inc.

K number K053211

View details →

DBF 2006-02-23

FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,

Applicant Good Biotech Corp.

K number K052617

View details →

DBF 2005-12-23

K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET

Applicant Kamiya Biomedical Co.

K number K050944

View details →

DBF 2004-05-10

QUANTEX FERRITIN

Applicant Instrumentation Laboratory CO

K number K040879

View details →

DBF 2003-07-17

FERRITIN GENERATION 2

Applicant Roche Diagnostics Corp.

K number K031650

View details →

DBF 2003-02-06

OLYMPUS FERRITIN REAGENT

Applicant Olympus America, Inc.

K number K030124

View details →

DBF 2002-02-19

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

Applicant Kamiya Biomedical Co.

K number K014293

View details →

DBF 2000-04-03

RANDOX FERRITIN

Applicant Randox Laboratories, Ltd.

K number K000662

View details →

DBF 1999-11-23

N LATEX FERRITIN

Applicant Dade Behring, Inc.

K number K993273

View details →

DBF 1999-09-24

BIOCHECK FERRITIN ELISA MODEL BC-1025

Applicant Biocheck, Inc.

K number K992517

View details →

DBF 1999-08-05

CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY

Applicant Chiron Diagnostics Corp.

K number K992157

View details →

DBF 1999-02-02

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY

Applicant Nichols Institute Diagnostics

K number K984186

View details →

DBF 1998-12-14

IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K983340

View details →

DBF 1998-12-07

ABBOTT ARCHITECT FERRITIN

Applicant Abbott Laboratories

K number K983759

View details →

DBF 1998-10-22

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY

Applicant Bayer Corp.

K number K982714

View details →

DBF 1998-02-17

AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

Applicant Alfa Biotech (Uk) , Ltd.

K number K974505

View details →

DBF 1997-10-22

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)

Applicant Ortho-Clinical Diagnostics, Inc.

K number K973331

View details →

DBF 1997-09-12

MODIFICATION OF OPUS FERRITIN TEST SYSTEM

Applicant Behring Diagnostics, Inc.

K number K973202

View details →

DBF 1997-06-24

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY

Applicant Sealite Sciences, Inc.

K number K970612

View details →

DBF 1996-12-02

OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT

Applicant Olympus America, Inc.

K number K963170

View details →

DBF 1995-07-05

UBI MAGIWEL FERRITIN QUANTITATIVE

Applicant United Biotech, Inc.

K number K951993

View details →

DBF 1995-06-20

AMERLITE FERRITIN II ASSAY

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K952286

View details →

DBF 1995-03-27

N LATEX FERRITIN

Applicant Behring Diagnostics, Inc.

K number K950707

View details →

DBF 1994-06-21

AXSYM FERRITIN

Applicant Abbott Laboratories

K number K935847

View details →

DBF 1994-01-28

DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K935528

View details →

DBF 1993-08-05

VISTA FERRITIN ASSAY

Applicant Syva Co.

K number K931576

View details →

DBF 1992-12-15

AIA-PACK FER CALIBRATION VERIFICATION TEST SET

Applicant Tosoh Medics, Inc.

K number K924858

View details →

DBF 1992-04-07

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY

Applicant Vitek Systems, Inc.

K number K920952

View details →

DBF 1992-01-28

MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K920046

View details →

DBF 1991-04-05

SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)

Applicant Serono-Baker Diagnostics, Inc.

K number K911175

View details →

DBF 1991-03-12

CIBA CORNING ACS FERRITIN IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K905770

View details →

DBF 1990-11-29

ELEGANCE FERRITIN ELISA

Applicant Bioclone Australia Pty , Ltd.

K number K904822

View details →

DBF 1990-04-02

LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.

Applicant London Diagnostics, Inc.

K number K901075

View details →

DBF 1989-12-04

MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K896585

View details →

DBF 1989-10-17

LAN.0800Q/2800Q

Applicant Amersham Corp.

K number K895872

View details →

DBF 1989-05-09

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

Applicant Amersham Corp.

K number K892362

View details →

DBF 1989-01-04

AFFINITY(TM) FERRITIN IMMUNIT(TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K885074

View details →

DBF 1988-12-27

FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K884683

View details →

DBF 1988-10-27

MICROMEDIC FERRITIN IRMA KIT

Applicant Icn Micromedic Systems

K number K883746

View details →

DBF 1988-01-27

AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800

Applicant Amersham Corp.

K number K874203

View details →

DBF 1987-12-02

ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM

Applicant Nichols Institute Diagnostics

K number K874572

View details →

DBF 1987-11-25

IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5

Applicant Diagnostic Products Corp.

K number K874031

View details →

DBF 1987-10-07

CIBA CORNING MAGIC LITE FERRITIN

Applicant Ciba Corning Diagnostics Corp.

K number K873573

View details →

DBF 1987-06-12

DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM

Applicant Diagnostic Systems Laboratories, Inc.

K number K871489

View details →

DBF 1987-03-12

FERRITIN MAB SOLID PHASE COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K870570

View details →

DBF 1987-02-10

COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS

Applicant Diagnostic Products Corp.

K number K870107

View details →

DBF 1987-01-16

BECKMAN EPSILON(TM) FERRITIN TEST KIT

Applicant Beckman Instruments, Inc.

K number K864437

View details →

DBF 1986-10-08

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K863345

View details →

DBF 1986-10-01

QUANTIMUNE(R) FERRITIN IRMA

Applicant Bio-Rad

K number K863487

View details →

DBF 1986-08-27

PHASE II FERRITIN RADIOIMMUNOASSAY KIT

Applicant Medical & Scientific Designs, Inc.

K number K862960

View details →

DBF 1986-06-19

IMMPULSE FERRITIN ASSAY REAGENT

Applicant Sclavo, Inc.

K number K862014

View details →

DBF 1986-03-28

ENZYMUN-TEST FERRITIN

Applicant Boehringer Mannheim Corp.

K number K860137

View details →

DBF 1984-11-19

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K844158

View details →

DBF 1984-05-25

DSL FERRITIN IRMA

Applicant Diagnostic Systems Laboratories, Inc.

K number K841925

View details →

DBF 1983-05-05

DIAGNON FERRITIN 125 I RIA KIT

Applicant Iagnon Corp.

K number K830580

View details →

DBF 1983-03-24

CORNING FERRITIN 125I RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K830591

View details →

DBF 1983-02-25

TANDEM-E -FER IMMUNOENZYMETRIC KIT

Applicant Hybritech, Inc.

K number K823871

View details →

DBF 1982-12-03

AUTOPAK FERRITIN TEST DELIVERY SYS

Applicant Micromedic Systems

K number K823275

View details →

DBF 1982-09-30

ANTISERA TO HUMAN FERRITIN

Applicant Kent Laboratories, Inc.

K number K822472

View details →

DBF 1981-12-30

125I FERRITIN RADIOIMMUNOASSAY KIT

Applicant Bio-Ria

K number K812901

View details →

DBF 1981-10-23

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS

Applicant Corning Medical & Scientific

K number K812786

View details →

DBF 1981-10-19

FERRITIN KIT

Applicant Hybritech, Inc.

K number K812597

View details →

DBF 1981-08-12

SPECTRO FEIRITIN

Applicant Ramco Laboratories, Inc.

K number K812056

View details →

DBF 1981-07-16

LEECO FERRITIN-QUANT DIAG. TEST KIT

Applicant Leeco Diagnostics, Inc.

K number K811880

View details →

DBF 1981-07-10

AUTOPAK-12 FERRITIN KIT

Applicant Micromedic Systems

K number K811808

View details →

DBF 1981-07-10

FERRITIN RIA KIT

Applicant Amersham Corp.

K number K811804

View details →

DBF 1980-09-16

NORDICLAB FERRITIN IRMA TEST

Applicant Nordiclab Intl.

K number K801989

View details →

DBF 1980-08-20

FERRIZYME FERRITIN ENZYME IMMUNOASSAY

Applicant Abbott Laboratories

K number K801676

View details →

DBF 1980-08-13

FERRITIN RIA KIT

Applicant Diagnostic Products Corp.

K number K801580

View details →

DBF 1980-04-16

FERRITIN CONTROLS CODE QAS.104

Applicant Amersham Corp.

K number K800657

View details →

DBF 1980-03-03

FERRITIN RIA KIT

Applicant Amersham Corp.

K number K800299

View details →

DBF 1979-12-31

CENTRIA FERRITIN RIA

Applicant Union Carbide Corp.

K number K792449

View details →

DBF 1979-12-18

FERRITIN RADIOIMMUNOASSAY

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K792442

View details →

DBF 1979-12-06

FERRITIN RIA KIT

Applicant Cis Radiopharmaceuticals, Inc.

K number K791860

View details →

DBF 1979-04-23

NEIA-FERRITIN ENZYMEIMMUNASSAY KIT

Applicant New England Immunology Assoc.

K number K790490

View details →

DBF 1979-04-23

VENTRE/SEP FERRITIN RIA

Applicant Ventrex Laboratories, Inc.

K number K790447

View details →

DBF 1978-04-10

NEIA-FERRITIN ENZYMEIMMUNOASSAY

Applicant New England Immunology Assoc.

K number K780490

View details →

DBF 1977-06-17

IN VITRO FERRITIN RIA TEST

Applicant Clinical Assays, Inc.

K number K770702

View details →