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Panels › Immunology › Product code JMG · Class 2

Radioimmunoassay (Two-Site Solid Phase), Ferritin

Regulation 866.5340

0510(k)s in 12 months (24 all time)
1recalls in 12 months (5 all time)
4recalls that name a 510(k)
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Top companies in JMG

Company510(k)sRecalls
Beckman Coulter, Inc.21
Siemens Healthcare Diagnostics, Inc.03
Bd Becton Dickinson Vacutainer Systems Preanalytic20
Boehringer Mannheim Corp.20
Corning Medical & Scientific20
Diagnostic Products Corp.20
Baxter Healthcare Corp10
Bio-Rad10
Bio-Rad Laboratories, Inc.10
Calbiochem-Behring Corp.10
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Heavy Metals Test
Open, Classified		 JMGNone listed
Jul 15, 2019Siemens Healthcare Diagnostics, Inc.
Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure
Terminated		 JMGK963498
Apr 17, 2017Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Terminated		 JMGK052082
K926221
Aug 15, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses
Terminated		 JMGK963498
Dec 24, 2013Siemens Healthcare Diagnostics, Inc.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Terminated		 JMGK963498

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