Biebrich Scarlet
Biebrich Scarlet is an acidic azo dye used in histology as a cytoplasmic counterstain, notably in the Masson's trichrome staining procedure where it stains muscle fibers and cytoplasm red, helping differentiate tissue components. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is ICN, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- ICN
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.