Orcein
Orcein is a natural dye derived from lichens used as a histological staining reagent in hematology and histopathology, commonly applied to demonstrate elastic fibers, hepatitis B surface antigen, and certain connective tissue elements in tissue sections. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission requirement. The product code is KKF and it is regulated under 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KKF
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.