Trypsin
Trypsin is a serine protease enzyme used in histology for antigen retrieval and in cell culture for detaching adherent cells, breaking peptide bonds to expose antigenic epitopes in fixed tissue sections for improved immunohistochemical staining. 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 IBG, regulated under 21 CFR 864.4400, in the Pathology medical specialty.
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Basic Information
- Product Code
- IBG
- Device Class
- FDA class 1
- Regulation Number
- 864.4400
- 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 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.