FDA.reportPublic FDA data

Rheumatoid factor IVD, kit, agglutination

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method.
GUDID devices
33
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00006136471257Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-70332017-10-27
00006136471264Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-70342017-10-27
00006136471295Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-75332017-10-27
08426950589334Rheumajet RF 100 TESTSBIOKIT, S.A.3000-70332016-09-23
08426950590613Rheumajet RF 50 TESTSBIOKIT, S.A.3000270342016-09-23
10859035006207Wampole Colorcard® RF ALERE NORTH AMERICA, LLC360452016-09-24
00850054026941QMedix™Diagnostic Automation, Inc.DACD 320-1002025-03-27
10722355001460Detector Lex RAImmunostics Company, IncRA-50U2016-09-21
10722355001477Detector Lex RAImmunostics Company, IncRA-100U2016-09-21
10722355001507Detector RheumacolImmunostics Company, IncRH-502016-09-21
10722355001514Detector RheumacolImmunostics Company, IncRH-1002016-09-21
10722355001521Detector Rheumacol LexImmunostics Company, IncRHLX-502016-09-21
10722355001538Detector Rheumacol LexImmunostics Company, IncRHLX-1002016-09-21
10673486002423Teco Diagnostics Rheumatoid Factor (RF) Reagent SetTECO DIAGNOSTICSRF-1002024-04-01
10758750006809VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68017292016-08-26
B224R201RF LATEX Test KitCENOGENICS CORPORATIONR-202021-05-27
20885380020213CARDINAL HEALTHCardinal Health 200, LLCB1077-192016-09-15
20885380020220CARDINAL HEALTHCardinal Health 200, LLCB1077-202016-09-15
00842768011054RapiTex® RFSiemens Healthcare Diagnostics Products GmbH104464172016-09-24
00842768011061RapiTex® RFSiemens Healthcare Diagnostics Products GmbH104464182016-09-24
00842768012754RapiTex® RFSiemens Healthcare Diagnostics Products GmbH104466022016-09-24
00816057020461ASI RF Direct Slide TestARLINGTON SCIENTIFIC, INC.NC-700025DC2016-07-08
00816057020478ASI RF Direct Slide Tests for ExportARLINGTON SCIENTIFIC, INC.NC-700025DC-E2016-07-08
00816057020492ASI RF Direct Slide TestARLINGTON SCIENTIFIC, INC.NC-700100DC-E2016-07-08
00816057020508ASI RF Direct Slide TestARLINGTON SCIENTIFIC, INC.NC-7001000DC2016-07-08
00816057021642ASI RF Direct Slide Test Control SetARLINGTON SCIENTIFIC, INC.NC-7050012016-07-08
00657498001264RaPET® RFSTANBIO LABORATORY, L.P.1155-0502016-09-23
00657498001271RaPET® RFSTANBIO LABORATORY, L.P.1155-1002016-09-23
00695684351007AIM RF TESTGERMAINE LABORATORIES, INC351002016-04-27
00628055726036Pulse Scientific Inc.Pulse Scientific Inc105032016-11-04
00613647001257Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-70332016-09-24
00613647001264Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-70342016-09-24
00613647001295Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.T3018-75332016-09-24