Immunohistochemistry Reagents And Kits
Immunohistochemistry Reagents and Kits are hematology/pathology devices used after primary tumor diagnosis by conventional histopathology to provide additional characterization of neoplasms using immunologic staining methods that identify specific antigens in tissue sections. These reagents and kits are used as adjuncts to traditional hematoxylin and eosin staining. They are classified as FDA Class 1 (General Controls), under product code NJT and regulation 21 CFR 864.1860 in the Hematology specialty (reviewed by the Pathology panel). The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NJT
- Device Class
- FDA class 1
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
Definition
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.