Control Material, Her-2/Neu, Immunohistochemistry
- US Product Code (FDA)
- NJWView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 864.1860View CFR Regulation →
- Medical specialty
- Hematology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
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Control Material, Her-2/Neu, Immunohistochemistry is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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