International Medical Devices Database

Manufacturer Address
Biogenex Laboratories, Inc., 49026 Milmont Dr, Fremont CA 94538-7301
Source
USFDA
1 Event
- Recall of Device Recall InSite HER2/neu Detection Kit

One device in the database

Device Recall InSite HER2/neu Detection Kit

Model / Serial
Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Brazil and Ecuador. No US distribution
Product Description
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Biogenex Laboratories, Inc.

One device in the database

Device Recall InSite HER2/neu Detection Kit