Sieves, Tissue
Tissue sieves are laboratory implements used in histopathology and cytopathology to fragment and disaggregate tissue specimens into single-cell or small-cluster suspensions for cytological examination, flow cytometry, or cell culture applications. 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 IDX, 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
- IDX
- 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 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.