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)
Top companies in DHR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2019 | The 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 |
DHR | K160070 |
| Oct 7, 2019 | The Binding Site Group, Ltd. Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) Terminated |
DHR | K162263 |
| Aug 9, 2019 | Randox 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 |
DHR | K972220 |
| May 10, 2019 | Phadia 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 |
DHR | K102673 K182747 |
| Mar 19, 2018 | Hycor 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 |
DHR | K994338 |
| Feb 21, 2018 | Hycor 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 |
DHR | K994338 |
| Feb 13, 2018 | Stanbio 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 |
DHR | K974370 |
| Jan 4, 2018 | The 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 |
DHR | K160070 |
| Oct 1, 2012 | Beckman 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 |
DHR | K963048 |
| May 14, 2012 | Thera 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 |
DHR | K941398 |
| Mar 8, 2012 | Beckman 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 |
DHR | K971788 |
| Jan 11, 2012 | Ortho-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 |
DHR | K041863 |
| Jul 27, 2011 | Beckman 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 |
DHR | K963048 |
| Mar 22, 2011 | Beckman 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 |
DHR | K971788 |
| Jul 19, 2003 | Zeus 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 |
DHR | K961277 |
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