Mucicarmine
Mucicarmine is a histological stain used primarily to detect mucin in tissue sections, useful for identifying mucinous carcinomas and certain fungal organisms such as Cryptococcus neoformans. 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 HZC, 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
- HZC
- 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 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.