ClearanceBrief
Panels › Immunology › Product code DHR · Class 2

System, Test, Rheumatoid Factor

Regulation 866.5775

0510(k)s in 12 months (144 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in DHR

DateFirm and productCodeLinked 510(k)
Nov 6, 2019The Binding Site Group, Ltd.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Terminated
DHRK160070
Oct 7, 2019The Binding Site Group, Ltd.
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Terminated
DHRK162263
Aug 9, 2019Randox Laboratories Ltd.
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic rea
Terminated
DHRK972220
May 10, 2019Phadia Ab
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-hepar
Terminated
DHRK102673
K182747
Mar 19, 2018Hycor Biomedical Inc
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUT
Open, Classified
DHRK994338
Feb 21, 2018Hycor Biomedical Inc
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows:
Completed
DHRK994338
Feb 13, 2018Stanbio Laboratory, LP
RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Co
Terminated
DHRK974370
Jan 4, 2018The Binding Site Group, Ltd.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement
Terminated
DHRK160070
Oct 1, 2012Beckman Coulter Inc.
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use
Terminated
DHRK963048
May 14, 2012Thera Test Laboratories, Inc.
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTe
Terminated
DHRK941398
Mar 8, 2012Beckman Coulter Inc.
SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the r
Terminated
DHRK971788
Jan 11, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrat
Terminated
DHRK041863
Jul 27, 2011Beckman Coulter Inc.
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry
Terminated
DHRK963048
Mar 22, 2011Beckman Coulter Inc.
SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is
Terminated
DHRK971788
Jul 19, 2003Zeus Scientific Inc
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
Terminated
DHRK961277

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