Gelatin
Gelatin is a protein-derived substance used in histopathology as an embedding medium for frozen sections and as an adhesive coating for glass slides to improve tissue section adhesion during staining procedures. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IEX, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IEX
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.