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
73–96 of 144
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180
Unipath , Ltd.
Immunology · 126d
Cleared Sep 07, 1988
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355
United Biotech, Inc.
Immunology · 29d
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 May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196
Orion Diagnostica, Inc.
Immunology · 43d
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 Jan 17, 1986
RA 80 EIKEN
K854820
Syn-Kit, Inc.
Immunology · 45d
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 Apr 04, 1984
SERATEST RF LATEX DETERMINATION
K840863
Seragen Diagnostics, Inc.
Immunology · 40d
Cleared Feb 10, 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049
Diagnostic Products Corp.
Immunology · 35d
Cleared Jun 30, 1983
SERO/TEX RED CELL RF TEST
K831597
Texas Immunology, Inc.
Immunology · 44d
Cleared Jun 08, 1983
RA-CHECK
K831467
Diagnostic Technology, Inc.
Immunology · 33d
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 May 21, 1982
SERO/TEX RF TEST
K821319
Texas Immunology, Inc.
Immunology · 17d
Cleared Nov 06, 1981
FIAX RHEUMATOID FACTOR TEST KIT
K812968
Intl. Diagnostic Technology
Microbiology · 15d
Cleared Nov 06, 1981
RA LATEX TEST
K812972
Oxoid U.S.A., Inc.
Microbiology · 14d