Sirius Red
Sirius Red is a highly sulfonated dye used in histology to stain collagen fibers in tissue sections, producing a red coloration that, under polarized light, shows birefringence allowing differentiation of collagen types. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls only with no premarket notification required. The product code is HZY, 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
- HZY
- 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 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.