Control Material, Her-2/Neu, Immunohistochemistry
The HER-2/Neu Immunohistochemistry Control Material is a laboratory accessory device used to control HER2/neu immunohistochemistry assays, providing standardized reference material for validating test performance. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJW and regulation 21 CFR 864.1860 in the Hematology specialty (reviewed by the Pathology panel). The device is eligible for third-party review and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NJW
- Device Class
- FDA class 2
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.