Atlas FDA

DDG

48 FDA 510(k) clearances · Product code

69 daysmedian time to decision
230 days90th percentile
48clearances measured

FDA profile

Official device name
Transferrin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5880
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
Access sTfR (K240987)Beckman Coulter, Inc.2024-07-03
Transferrin (K190495)Biosystems S.A.2020-03-16
Tina-quant Transferrin ver.2 (urine application) (K182095)Roche Diagnostics Operations (Rdo)2018-11-05
TRANSFERRIN KIT FOR USE ON THE SPAPLUS (K120236)The Binding Site Group , Ltd.2013-02-13
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 (K080634)Beckman Coulter, Inc.2008-08-11
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA (K081299)Siemens Healthcare Diagnostics, Inc.2008-08-08
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (K063086)Thermo Electron OY2007-08-08
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C (K063766)Good Biotech Corp.2007-04-23
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K063663)Dade Behring, Inc.2007-03-21
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H (K063322)Dade Behring, Inc.2007-01-24
N ANTISERA TO HUMAN TRANSFERRIN (K053075)Dade Behring, Inc.2006-03-16
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN (K042477)Ortho-Clinical Diagnostics, Inc.2004-11-19
TINA-QUANT TRANSFERRIN VER.2 (K012371)Roche Diagnostics Corp.2001-09-19
TINA-QUANT TRANSFERRIN VER.2 (K012393)Roche Diagnostics Corp.2001-09-19
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL (K011662)The Binding Site, Ltd.2001-07-30
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 (K003064)Roche Diagnostics Corp.2001-05-01
RANDOX TRANSFERRIN (K002585)Randox Laboratories, Ltd.2001-02-05
DIMENSION TRNF FLEX REAGENT CARTRIDGE (K994294)Dade Behring, Inc.2000-02-04
K-ASSAY TRANSFERRIN (K993537)Kamiya Biomedical Co.1999-11-30
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR (K993162)Wako Chemicals USA, Inc.1999-11-12
N LATEX STFR REAGENT (K991157)Dade Behring, Inc.1999-08-02
TRANSFERRIN SPQ III ANTIBODY REAGENT SET (K983880)DiaSorin, Inc.1998-12-18
TRF (K983167)Abbott Laboratories1998-11-04
N ANTISERUM TO HUMAN TRANSFERRIN (K972840)Behring Diagnostics, Inc.1997-10-17
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT (K971958)Beckman Instruments, Inc.1997-08-20
N-ASSAY TIA TRANSFERRIN TEST KIT (K964295)Crestat Diagnostics, Inc.1997-06-16
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT (K963976)Beckman Instruments, Inc.1997-03-19
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT (K963427)Beckman Instruments, Inc.1996-10-07
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY (K933589)Boehringer Mannheim Corp.1993-11-03
BECKMAN TRANSFERRIN KIT (K926272)Beckman Instruments, Inc.1993-10-07
IL TEST(TM) TRANSFERRIN (TRF) (K914993)Instrumentation Laboratory CO1992-01-17
TRANSFERRIN RID KIT (K914390)The Binding Site, Ltd.1991-12-09
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT (K900875)Reagents Applications, Inc.1990-03-06
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (K890563)Atlantic Antibodies1989-03-03
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (K884075)Orion Diagnostica, Inc.1988-10-19
TRANSFERRIN (K873867)Unipath , Ltd.1987-10-13
QM300 TRANSFERRIN ANTIBODY PACK (K873789)Kallestad Diag, A Div. of Erbamont, Inc.1987-10-07
TINA-QUANT [A] TRANSFERRIN (K871896)Boehringer Mannheim Corp.1987-06-15
PRECIMAT(R) TRANSFERRIN (K871022)Boehringer Mannheim Corp.1987-05-14
TDX TRANSFERRIN DIAGNOSTIC KIT (K854416)Abbott Laboratories1986-02-21
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN (K851287)Cooper Biomedical, Inc.1985-05-24
SPQ TEST SYSTEM FOR TRANSFERRIN (K850589)Applications Lab1985-03-05
RADIAL IMMUNODIFFUSION PLATES (K830911)Biocell Laboratories, Inc.1983-06-10
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY (K813288)New England Immunology Assoc.1981-12-17
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN (K812492)Dako Corp.1981-09-23
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST (K811613)Kent Laboratories, Inc.1981-08-12
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (K801434)J.T. Baker Chemical Co.1980-07-08
TRANSFERRIN NEPHELOMETRIC ASSAY (K772253)Kallestad Laboratories, Inc.1977-12-22

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