Toluidine Blue
Toluidine Blue is a cationic metachromatic dye used in histology to stain nucleic acids (blue-purple) and sulfated polysaccharides (red-purple), commonly applied to sections of cartilage, mast cells, and nerve tissue. 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 IAB, 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
- IAB
- 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 |
|---|---|---|---|---|
| K844640 | POLYSTAT, BIOLOGICAL STAIN | Jan 30, 1985 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.