Product code NJW
- Device name
- Control Material, Her-2/Neu, Immunohistochemistry
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
- Source
- FDA openFDA device classification dataset