Peroxidase Anti-Peroxidase Immunohistochemical Stain
The peroxidase anti-peroxidase (PAP) immunohistochemical stain is a laboratory reagent system used in pathology to detect specific antigens in tissue sections using a complex of peroxidase enzyme and antibody, allowing visualization of the target antigen via enzyme-mediated color development. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LIJ and is regulated under 21 CFR 864.4400 within the Pathology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LIJ
- Device Class
- FDA class 1
- Regulation Number
- 864.4400
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.