Product code DHR
- Device name
- System, Test, Rheumatoid Factor
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5775
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | 2020-05-20 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | 2019-04-17 |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018-12-18 |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | 2017-05-03 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2016-12-07 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Immco Diagnostics, Inc. | 2015-09-23 |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2011-09-30 |
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | Orgentec Diagnostika GmbH | 2010-10-27 |
| K083080 | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | Sqi Diagnostics Systems | 2009-10-29 |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | 2007-08-08 |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Olympus America, Inc. | 2006-06-06 |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | The Binding Site | 2004-11-05 |
| K041863 | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | Zeus Scientific, Inc. | 2004-02-27 |
| K032535 | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | 2003-09-10 |
| K024067 | RHEUMATOID FACTOR (RF) | Abbott Laboratories | 2003-01-15 |
| K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | Wako Chemicals USA, Inc. | 2002-09-09 |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Diamedix Corp. | 2002-07-09 |
| K002609 | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | 2000-09-05 |
| K000534 | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | Roche Diagnostics Corp. | 2000-04-05 |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Cogent Diagnotics , Ltd. | 2000-03-03 |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Cogent Diagnotics , Ltd. | 2000-02-03 |
| K993843 | MDI RF TEST | Micro Detect, Inc. | 2000-01-11 |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Cogent Diagnotics , Ltd. | 1999-12-06 |
| K991467 | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | Kamiya Biomedical Co. | 1999-06-10 |
| K991409 | K-ASSAY RHEUMATOID FACTOR | Kamiya Biomedical Co. | 1999-06-09 |
| K990587 | ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 | Bio-Rad | 1999-04-07 |
| K990035 | RF | Abbott Laboratories | 1999-03-08 |
| K984045 | RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS | Kamiya Biomedical Co. | 1999-01-25 |
| K983418 | THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL | Zeus Scientific, Inc. | 1998-11-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07333066024325 | EliA RF IgM Well | Phadia AB | 2026-01-29 |
| 07333066024134 | EliA RF IgA Well | Phadia AB | 2026-01-29 |
| 07333066024110 | EliA RF IgM Well | Phadia AB | 2026-01-29 |
| 07333066024332 | EliA RF IgA Well | Phadia AB | 2026-01-29 |
| 00850054026941 | QMedix™ | Diagnostic Automation, Inc. | 2025-03-27 |
| 07333066013138 | EliA IgM Conjugate 200 | Phadia AB | 2021-04-30 |
| 00816426021457 | K-ASSAY® RF Reagent (Ver.2) | KAMIYA BIOMEDICAL COMPANY, LLC | 2020-11-03 |
| 00006136471257 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471264 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471295 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002960 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 10859035006207 | Wampole Colorcard® RF | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006009 | RHEUMATEX® | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 08426950590477 | RF Titer Control | BIOKIT, S.A. | 2016-09-23 |
| 07333066014821 | EliA RF IgA Well | Phadia AB | 2016-09-23 |
| 07333066014814 | EliA RF IgM Well | Phadia AB | 2016-09-23 |
| 08426950590613 | Rheumajet RF 50 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 04015630919802 | Tina-quant RF II | Roche Diagnostics GmbH | 2016-09-23 |
| 08426950589334 | Rheumajet RF 100 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 04015630927357 | Rheumatoid Factors II | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919925 | Tinaquant RF II | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916566 | RF Control Set | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630914531 | Preciset RF | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630914524 | Rheumatoid Factors II | Roche Diagnostics GmbH | 2016-09-20 |
| 08426950593423 | QUANTA Lite® RF IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593416 | QUANTA Lite® RF IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593188 | QUANTA Lite® RF IgM ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |