Fluid, Bouin'S
Bouin's Fluid is a compound tissue fixative used in pathology and histology laboratories, composed of picric acid, formalin, and acetic acid, widely employed for the preservation of small biopsy specimens, embryonic tissues, and gastrointestinal biopsies due to its superior penetration and ability to preserve tissue architecture and nuclear detail. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IGN, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IGN
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- 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 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.