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Devices
PATHWAY HER2 (4B5)
Model / Serial
Lot number: 680957
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
Product Description
VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY || (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
Manufacturer
Ventana Medical Systems Inc
1 Event
Recall of PATHWAY HER2 (4B5)
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Manufacturer
Ventana Medical Systems Inc
Manufacturer Address
Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
USFDA
Language
English
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