DHR · Class II · 21 CFR 866.5775

FDA Product Code DHR: System, Test, Rheumatoid Factor

Leading manufacturers include Behring Diagnostics, Inc., Beckman Instruments, Inc. and Inova Diagnostics, Inc..

144
Total
144
Cleared
80d
Avg days
1976
Since
144 devices
25–48 of 144
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587
Bio-Rad
Immunology · 43d
Cleared Mar 08, 1999
RF
K990035
Abbott Laboratories
Immunology · 61d
Cleared Jan 25, 1999
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
K984045
Kamiya Biomedical Co.
Immunology · 73d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
K983418
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 04, 1998
QUANTA LITE RF IGG ELISA
K983083
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
QUANTA LITE RF IGA ELISA
K983084
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Jun 15, 1998
COLOR-SLIDE RF
K981496
Seradyn, Inc.
Immunology · 49d
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889
Diamedix Corp.
Immunology · 66d
Cleared Feb 17, 1998
RAPET RF
K974370
Stanbio Laboratory
Immunology · 89d
Cleared Nov 25, 1997
RHEUMACOL RHEUMATOID FACTOR TEST
K972456
Immunostics Inc.,
Immunology · 147d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464
Instrumentation Laboratory CO
Immunology · 40d
Cleared Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220
Randox Laboratories, Ltd.
Immunology · 89d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 20, 1997
QUANTA LITE RF IGM
K971614
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379
Boehringer Mannheim Corp.
Immunology · 64d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788
Beckman Instruments, Inc.
Immunology · 20d
Cleared Apr 17, 1997
RAICHEM RHEUMATOID FACTOR SPIA
K970373
Henage Diagnostics, Inc.
Immunology · 73d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Dec 16, 1996
THERATEST EL-RFSCR
K962050
Theratest Laboratories, Inc.
Immunology · 202d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
K964415
Kamiya Technology Services
Immunology · 73d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
K964418
Kamiya Technology Services
Immunology · 73d
Cleared Nov 25, 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015
Teco Diagnostics
Immunology · 187d
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048
Beckman Instruments, Inc.
Immunology · 90d
Cleared Sep 24, 1996
QUALITROL RF CONTROLS
K961545
Consolidated Technologies, Inc.
Immunology · 155d