Ovens, Paraffin
A paraffin oven is a laboratory heating device used in histopathology to maintain paraffin wax in a molten state for tissue embedding and infiltration, supporting the preparation of tissue blocks for microtome sectioning. 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 IDR, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IDR
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.