Eosin B
Eosin B is an acidic red dye used in histology as a cytoplasmic counterstain, often paired with hematoxylin in the H&E staining method, staining cytoplasm, collagen, and other eosinophilic structures pink to red. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is ICC, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
Research product code ICC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- ICC
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K810684 | HEMOCOLOR STAIN SET | Apr 08, 1981 | Substantially Equivalent | Harleco |
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.