ClearanceBrief
Panels › Immunology › Product code DDG · Class 2

Transferrin, Antigen, Antiserum, Control

Regulation 866.5880

0510(k)s in 12 months (48 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in DDG

Company510(k)sRecalls
Dade Behring, Inc.50
Beckman Instruments, Inc.40
Roche Diagnostics Corp.31
Abbott Laboratories21
Boehringer Mannheim Corp.30
Randox Laboratories, Ltd.12
Beckman Coulter, Inc.20
The Binding Site, Ltd.20
Roche Diagnostics Operations, Inc.02
Applications Lab10
DateFirm and productCodeLinked 510(k)
Jun 9, 2022Randox Laboratories Ltd.
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Terminated		 DDGK002585
Jun 9, 2022Randox Laboratories Ltd.
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Terminated		 DDGK002585
Aug 28, 2019Roche Diagnostics Operations, Inc.
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
Terminated		 DDGK003064
Aug 28, 2019Roche Diagnostics Operations, Inc.
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Terminated		 DDGK003064
May 16, 2018Abbott Laboratories, Inc
Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming a
Terminated		 DDGK983167
Oct 9, 2008Roche Diagnostics Corp.
Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for u
Terminated		 DDGK003064

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