Atlas FDA

DHR

144 FDA 510(k) clearances · Product code

52 daysmedian time to decision
182 days90th percentile
144clearances measured

FDA profile

Official device name
System, Test, Rheumatoid Factor
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5775
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 2010: 19 · 2011: 400 · 2012: 91
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (K192727)Kamiya Biomedical Company2020-05-20
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (K190088)Inova Diagnostics, Inc.2019-04-17
EliA RF IgM Immunoassay (K182747)Phadia AB2018-12-18
Optilite Rheumatoid Factor Kit (K162263)The Binding Site Group , Ltd.2017-05-03
Rheumatoid Factor (RF) Kit for use on SPAPLUS (K160070)The Binding Site Group , Ltd.2016-12-07
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA (K143736)Immco Diagnostics, Inc.2015-09-23
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K102673)Phadia US, Inc.2011-09-30
ORGENTEC RHEUMATOID FACTOR EIA (K100499)Orgentec Diagnostika GmbH2010-10-27
IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (K083080)Sqi Diagnostics Systems2009-10-29
N LATEX RF KIT (K071247)Dade Behring, Inc.2007-08-08
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. (K060201)Olympus America, Inc.2006-06-06
MININEPH HUMAN RHEUMATOID FACTOR KIT (K041891)The Binding Site2004-11-05
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS (K041863)Ortho-Clinical Diagnostics, Inc.2004-09-20
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM (K033802)Zeus Scientific, Inc.2004-02-27
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K032535)Roche Diagnostics Corp.2003-09-10
RHEUMATOID FACTOR (RF) (K024067)Abbott Laboratories2003-01-15
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET (K020972)Wako Chemicals USA, Inc.2002-09-09
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (K021394)Diamedix Corp.2002-07-09
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609)Roche Diagnostics Corp.2000-09-05
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II (K000534)Roche Diagnostics Corp.2000-04-05
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (K993557)Cogent Diagnotics , Ltd.2000-03-03
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (K994338)Cogent Diagnotics , Ltd.2000-02-03
MDI RF TEST (K993843)Micro Detect, Inc.2000-01-11
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (K993304)Cogent Diagnotics , Ltd.1999-12-06
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET (K991467)Kamiya Biomedical Co.1999-06-10
K-ASSAY RHEUMATOID FACTOR (K991409)Kamiya Biomedical Co.1999-06-09
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 (K990587)Bio-Rad1999-04-07
RF (K990035)Abbott Laboratories1999-03-08
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS (K984045)Kamiya Biomedical Co.1999-01-25
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL (K983418)Zeus Scientific, Inc.1998-11-18
QUANTA LITE RF IGA ELISA (K983084)Inova Diagnostics, Inc.1998-11-04
QUANTA LITE RF IGG ELISA (K983083)Inova Diagnostics, Inc.1998-11-04
COLOR-SLIDE RF (K981496)Seradyn, Inc.1998-06-15
DIAMEDIX IS-RF TEST SYSTEM (K974889)Diamedix Corp.1998-03-06
RAPET RF (K974370)Stanbio Laboratory1998-02-17
RHEUMACOL RHEUMATOID FACTOR TEST (K972456)Immunostics Inc.,1997-11-25
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) (K973464)Instrumentation Laboratory CO1997-10-22
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT (K972220)Randox Laboratories, Ltd.1997-09-09
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT (K971602)Beckman Instruments, Inc.1997-06-27
QUANTA LITE RF IGM (K971614)Inova Diagnostics, Inc.1997-06-20
TINAQUANT RHEUMATOID FACTOR ASSAY (K971379)Boehringer Mannheim Corp.1997-06-17
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR (K971788)Beckman Instruments, Inc.1997-06-03
RAICHEM RHEUMATOID FACTOR SPIA (K970373)Henage Diagnostics, Inc.1997-04-17
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY (K962729)Hycor Biomedical, Inc.1997-03-07
THERATEST EL-RFSCR (K962050)Theratest Laboratories, Inc.1996-12-16
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT (K964415)Kamiya Technology Services1996-12-13
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET (K964418)Kamiya Technology Services1996-12-13
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST (K962015)Teco Diagnostics1996-11-25
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT (K963048)Beckman Instruments, Inc.1996-11-04
QUALITROL RF CONTROLS (K961545)Consolidated Technologies, Inc.1996-09-24
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) (K962836)Hemagen Diagnostics, Inc.1996-09-12
RHEUMATOID FACTOR LATEX SLIDE TEST KIT (K961169)Randox Laboratories, Ltd.1996-06-26
LIQUICHEK RHEUMATOID FACTOR CONTROL (K960987)Bio-Rad1996-06-04
RF IGM ELISA TEST SYSTEM (K961277)Zeus Scientific, Inc.1996-05-08
RF-LATEX SEIKEN REAGENT SYSTEM (K960703)Globe Management Support, Inc.1996-04-19
HYTEC AUTOMIMMUNE KIT (RF) (K954892)Hycor Biomedical, Inc.1995-12-26
TEST, RHEUMATOID FACTOR (K955086)Polymedco, Inc.1995-12-20
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT (K953520)Olympus America, Inc.1995-08-24
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (K953261)Shared Systems, Inc.1995-08-15
EL-RF/3 (IGM-IGG-IGA) KIT (K941398)Theratest Laboratories, Inc.1995-07-28
IGM RF EIA (K942908)Sigma Diagnostics, Inc.1995-01-20
N LATEX RF (K942328)Behring Diagnostics, Inc.1994-10-20
IGM RHEUMATOID FACTOR (K942272)Immco Diagnostics, Inc.1994-09-26
EL-RF TEST SYSTEM: EL-RF-IGM KIT (K933712)Theratest Laboratories, Inc.1994-01-28
EYE SPOT RF TEST (K932437)J & S Medical Assoc., Inc.1993-08-23
IMMUNO RA UNDILUTED (K926569)Immunostics Co., Inc.1993-04-06
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST (K915320)Trinity Laboratories, Inc.1992-12-07
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (K924036)J.S. Medical Assoc.1992-12-01
LIQUICHEK RHEUMATOID FACTOR CONTROL (K923578)Bio-Rad1992-10-06
PULSE RF TEST (K923771)Pulse Scientific, Inc.1992-10-05
TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL (K922725)Simplicity Diagnostics, Inc.1992-10-05
ENCORE RHEUMATOID FACTOR EIA (K924056)Clark Laboratories, Inc.1992-09-25
WAKO AUTOKIT RF (K922151)Wako Chemicals USA, Inc.1992-07-28
RF STAT IGM TEST KIT (K920753)Biowhittaker Molecular Applications, Inc.1992-03-30
HEALTHTEST RHEUMATOID FACTOR ASSAY (K920220)Akers Research Corp.1992-03-13
TURBIQUANT (K920124)Behring Diagnostics, Inc.1992-03-02
RHEUMAGEN RF T-CONTROL (K904310)Biokit USA, Inc.1991-05-31
RHEUMAJET RF (K910539)Biokit USA, Inc.1991-04-05
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST (K904498)Biotrax, Inc.1990-10-29
V-TREND TARGET RF TEST (K904105)Texas Immunology, Inc.1990-10-15
RAPITEX(R) RF NEW (K903852)Behring Diagnostics, Inc.1990-08-30
MODIFIED QM300 RHEUMATOID FACTOR TEST (K902462)Kallestad Diag, A Div. of Erbamont, Inc.1990-06-21
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (K896271)Biokit USA, Inc.1989-11-08
TECHNICON DPA-1 SYSTEM RF METHOD (K894574)Technicon Instruments Corp.1989-08-10
REAADS-RF TEST KIT-SEMIQUANTITATIVE (K892445)Biosearch Medical Products, Inc.1989-06-05
REAADS-RF TEST KIT-QUANTITATIVE (K892444)Biosearch Medical Products, Inc.1989-06-05
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K884180)Unipath , Ltd.1989-02-03
UBI MAGIWEL RF-IGM QUANTITATIVE (K883355)United Biotech, Inc.1988-09-07
QM300 CALIBRATOR E PACK (K883538)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
QM300 RHEUMATOID FACTOR ANTIGEN PACK (K883536)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
RF CARD TEST & RF LIQUID TEST (K880164)Ampcor, Inc.1988-02-10
RF DIPSTICK TEST KIT (K874151)Lipogen, Inc.1987-12-29
REUMA TEST (K873782)Sclavo, Inc.1987-11-27
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT (K873064)Amtec Diagnostics International, Inc.1987-11-04
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST (K871196)Orion Diagnostica, Inc.1987-05-06
RF MICROASSAY (K871041)Diamedix Corp.1987-03-31
READS RF TEST KIT FOR IGM RHEUMATOID FACTOR (K863238)Biostar Medical Products, Inc.1986-10-08
SERATEST RF (HEMAGGLUTINATION) KIT (K855221)Hemagen Diagnostics, Inc.1986-04-22
DIESSE RF TEST KIT (K854222)Marvic Interpharma, Inc.1986-02-06
RA 80 EIKEN (K854820)Syn-Kit, Inc.1986-01-17
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