Product Code: MVC

Products Classified as MVC

5037

System, Test, Her-2/neu, Ihc

Total Product Life Cycle (TPLC) Devices

5037

System, Test, Her-2/neu, Ihc

Pre-market Approvals for MVC

P980018	Hercep Test	DAKO A/S
P990081	PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody	VENTANA MEDICAL SYSTEMS, INC.
P090015	BOND Oracle HER2 IHC System	Leica Biosystems

Global Unique Device Identification Database

• 05700572032007: System, Test, Her-2/Neu, Ihc
• 05700572031994: System, Test, Her-2/Neu, Ihc
• 05700572031987: System, Test, Her-2/Neu, Ihc
• 05055331301291: System, Test, Her-2/Neu, Ihc

Maude Adverse Events

HERCEPTEST FOR AUTOMATED LINK PLATFORMS	DAKO DENMARK A/S	2018-06-13
HERCEPTEST FOR THE DAKO AUTOSTAINER	DAKO DENMARK A/S	2018-06-13
BOND ORACLE HER2 IHC SYSTEM	LEICA BIOSYSTEMS NEWCASTLE LTD.	2016-02-10
BOND ORACLE HER2 IHC SYSTEM	LEICA BIOSYSTEMS NEWSCASTLE LTD	2016-02-10
BOND ORACLE HER2 IHC SYSTEM	LEICA BIOSYSTEMS NEWCASTLE LTD	2016-02-10
HERCEPTEST	DAKO DENMARK A/S	2015-12-04
HERCEPTEST	DAKO DENMARK A/S	2015-12-03
HERCEPTEST	DAKO DENMARK A/S	2015-11-17
BOND? ORACLE? HER2 IHC SYSTEM	LEICA BIOSYSTEMS NEWCASTLE LTD.	2015-10-13
PATHYWAY ANTI-HER-2/NEU (4B5) RABBIT MONO	VENTANA MEDICAL SYSTEMS, INC.	2014-07-25
BOND ORACLE HER2 IHC SYSTEM	LEICA BIOSYSTEMS NEWCASTLE LTD.	2013-08-27
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2013-03-13
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2012-11-01
CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2012-03-20
HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2009-12-22
HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2009-12-22
HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2009-10-16
HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY	VENTANA MEDICAL SYSTEMS, INC.	2009-09-25