Oil Red O
Oil Red O is a fat-soluble dye used in histology to stain neutral lipids and triglycerides in frozen tissue sections, producing a bright red coloration in lipid-containing structures. It is regulated as an FDA Class 1 device, the lowest risk level, subject only to general controls with no premarket notification required. The product code is HZG, 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
- HZG
- 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 |
|---|---|---|---|---|
| K781122 | LIPOPROTEIN STAIN | Aug 31, 1978 | Substantially Equivalent | Electrophoresis Corp. of America |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.