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
49–72 of 144
Cleared Aug 30, 1990
RAPITEX(R) RF NEW
K903852
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 17d
Cleared Aug 10, 1989
TECHNICON DPA-1 SYSTEM RF METHOD
K894574
Technicon Instruments Corp.
Immunology · 20d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180
Unipath , Ltd.
Immunology · 126d
Cleared Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
QM300 CALIBRATOR E PACK
K883538
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Nov 27, 1987
REUMA TEST
K873782
Sclavo, Inc.
Immunology · 72d
Cleared Mar 31, 1987
RF MICROASSAY
K871041
Diamedix Corp.
Microbiology · 14d
Cleared Apr 22, 1986
SERATEST RF (HEMAGGLUTINATION) KIT
K855221
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Jun 05, 1985
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537
Behring Diagnostics, Inc.
Immunology · 50d
Cleared Apr 12, 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373
Abbott Laboratories
Chemistry · 29d
Cleared Oct 25, 1984
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896
Diagnostic Products Corp.
Immunology · 22d
Cleared Apr 25, 1984
RF TEST KIT
K841454
Difco Laboratories, Inc.
Immunology · 16d
Cleared Feb 10, 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049
Diagnostic Products Corp.
Immunology · 35d
Cleared Apr 18, 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832
Emd Chemicals, Inc.
Immunology · 33d
Cleared Oct 18, 1982
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905
Fisher Scientific Co., LLC
Immunology · 19d
Cleared Aug 27, 1982
RHEUMATOID FACTOR REFERENCE PREPARA.
K821941
Armkel, LLC
Immunology · 59d
Cleared Nov 06, 1981
RA LATEX TEST
K812972
Oxoid U.S.A., Inc.
Microbiology · 14d
Cleared Oct 26, 1981
RHEUMATEX
K812882
Armkel, LLC
Microbiology · 12d
Cleared Mar 11, 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306
Beckman Instruments, Inc.
Immunology · 34d
Cleared Mar 11, 1981
RHEUMATOID FACTORS REFERENCE SERUM
K810404
Calbiochem-Behring Corp.
Microbiology · 21d