Congo Red
Congo Red is a direct diazo dye used in histology to stain amyloid deposits in tissue sections, producing a characteristic apple-green birefringence under polarized light that distinguishes amyloid from other eosinophilic deposits. 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 ICH, 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
- ICH
- 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 |
|---|---|---|---|---|
| K840798 | AMYLOID STAIN, CONGO RED HT 60 | Mar 12, 1984 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.