Bath, Flotation, Tissue
A tissue flotation bath is a laboratory water bath used in histopathology to float and flatten thin paraffin-embedded tissue sections cut by the microtome onto a water surface before pickup onto glass slides, reducing wrinkles and folds in the section. 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 IDY, 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
- IDY
- 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 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.