Devices

EnVision FLEX

Model / Serial
Catalog Number: K8000, K8002, GV800 Batch Number: 20019097, 20020777, 20021381, 20019103, 20019113, 20020772, 20020773, 20023052, 20021362, 20020792, 20021384, 20020768, 20019099, 20019102
Product Description
Diagnostic medical devices in vitro
Manufacturer
Dako Denmark A/S
1 Event
- Field Safety Notices about EnVision FLEX

Manufacturer

Dako Denmark A/S

Manufacturer Parent Company (2017)
Agilent Technologies, Inc.
Source
MHSIDCCCDMIS

18 devices with a similar name

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Envision FLEX, High pH (link)

Model / Serial
Envision FLEX, High pH (link), K8023, lots 20020777 and || 20019097
Product Description
Determination of the different related analytes in samples from the human body
Manufacturer
DAKO || Importer: ROCHEM BIOCARE DE COLOMBIA

EnVision FLEX+ MOUSE HIGH PH Link

Model / Serial
20019103 2 || 20019113 20 || 20020772 2 || 20020773 || 20023052
Product Description
Determination of the different analytes related to samples from human origin
Manufacturer
DAKO INC. || Importer: ROCHEM BIOCARE

Dako EnVision FLEX/HPR reagent

Model / Serial
Model: K8000 & K8012, Affected: 20019097 & 20020768
Manufacturer
DakoCytomation

envision flex

Model / Serial
Product Description
ivd
Manufacturer
DAKO DENMARK A/S

Device Recall EnVision FLEX, Mouse, High pH (Link)

Model / Serial
K8002 Lot no: 10112879 K8004 Lot no: 10111463
Distribution
Worldwide Distribution -- US, Canada, and Colombia.
Product Description
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. || Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Manufacturer
Dako Denmark A/S

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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