Product code DHR— Immunology
LIQUICHEK RHEUMATOID FACTOR CONTROL
- Classification name
- System, Test, Rheumatoid Factor
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Total cleared
- 144
- First cleared
- Most recent
Market context for product code DHR
FDA has cleared devices under product code DHR between 1976 and 2020, filed by 93 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2011
- 2010
- 2009
- 2007
- 2006
- 2004
- 2003
- 2002
- 2000
Top applicants under product code DHR
Recent clearances under product code DHR
1–100 of 144- K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
- K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
- K182747 — EliA RF IgM Immunoassay
- K162263 — Optilite Rheumatoid Factor Kit
- K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS
- 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
- K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
- K100499 — ORGENTEC RHEUMATOID FACTOR EIA
- K083080 — IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
- K071247 — N LATEX RF KIT
- K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
- K041891 — MININEPH HUMAN RHEUMATOID FACTOR KIT
- K041863 — VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
- K033802 — ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
- K032535 — MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K024067 — RHEUMATOID FACTOR (RF)
- K020972 — WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
- K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
- K002609 — TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K000534 — COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
- K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
- K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
- K993843 — MDI RF TEST
- K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
- K991467 — K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
- K991409 — K-ASSAY RHEUMATOID FACTOR
- K990587 — ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
- K990035 — RF
- K984045 — RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
- K983418 — THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
- K983083 — QUANTA LITE RF IGG ELISA
- K983084 — QUANTA LITE RF IGA ELISA
- K981496 — COLOR-SLIDE RF
- K974889 — DIAMEDIX IS-RF TEST SYSTEM
- K974370 — RAPET RF
- K972456 — RHEUMACOL RHEUMATOID FACTOR TEST
- K973464 — QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
- K972220 — RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
- K971602 — ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
- K971614 — QUANTA LITE RF IGM
- K971379 — TINAQUANT RHEUMATOID FACTOR ASSAY
- K971788 — SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
- K970373 — RAICHEM RHEUMATOID FACTOR SPIA
- K962729 — HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
- K962050 — THERATEST EL-RFSCR
- K964415 — N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
- K964418 — N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
- K962015 — RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
- K963048 — IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
- K961545 — QUALITROL RF CONTROLS
- K962836 — HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
- K961169 — RHEUMATOID FACTOR LATEX SLIDE TEST KIT
- K960987 — LIQUICHEK RHEUMATOID FACTOR CONTROL
- K961277 — RF IGM ELISA TEST SYSTEM
- K960703 — RF-LATEX SEIKEN REAGENT SYSTEM
- K954892 — HYTEC AUTOMIMMUNE KIT (RF)
- K955086 — TEST, RHEUMATOID FACTOR
- K953520 — OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
- K953261 — CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
- K941398 — EL-RF/3 (IGM-IGG-IGA) KIT
- K942908 — IGM RF EIA
- K942328 — N LATEX RF
- K942272 — IGM RHEUMATOID FACTOR
- K933712 — EL-RF TEST SYSTEM: EL-RF-IGM KIT
- K932437 — EYE SPOT RF TEST
- K926569 — IMMUNO RA UNDILUTED
- K915320 — RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
- K924036 — ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
- K923578 — LIQUICHEK RHEUMATOID FACTOR CONTROL
- K922725 — TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
- K923771 — PULSE RF TEST
- K924056 — ENCORE RHEUMATOID FACTOR EIA
- K922151 — WAKO AUTOKIT RF
- K920753 — RF STAT IGM TEST KIT
- K920220 — HEALTHTEST RHEUMATOID FACTOR ASSAY
- K920124 — TURBIQUANT
- K904310 — RHEUMAGEN RF T-CONTROL
- K910539 — RHEUMAJET RF
- K904498 — CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
- K904105 — V-TREND TARGET RF TEST
- K903852 — RAPITEX(R) RF NEW
- K902462 — MODIFIED QM300 RHEUMATOID FACTOR TEST
- K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
- K894574 — TECHNICON DPA-1 SYSTEM RF METHOD
- K892444 — REAADS-RF TEST KIT-QUANTITATIVE
- K892445 — REAADS-RF TEST KIT-SEMIQUANTITATIVE
- K884180 — TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
- K883355 — UBI MAGIWEL RF-IGM QUANTITATIVE
- K883536 — QM300 RHEUMATOID FACTOR ANTIGEN PACK
- K883538 — QM300 CALIBRATOR E PACK
- K880164 — RF CARD TEST & RF LIQUID TEST
- K874151 — RF DIPSTICK TEST KIT
- K873782 — REUMA TEST
- K873064 — AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
- K871196 — RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
- K871041 — RF MICROASSAY
- K863238 — READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
- K855221 — SERATEST RF (HEMAGGLUTINATION) KIT
- K854222 — DIESSE RF TEST KIT
- K854820 — RA 80 EIKEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.