Agent, Chelating For Decalcification
A chelating agent for decalcification is a laboratory reagent, typically containing compounds such as EDTA, that binds and removes calcium ions from fixed bone or mineralized tissue specimens through a gentler chemical mechanism than acid-based decalcifiers, preserving tissue morphology and antigenicity for histopathological analysis. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KDY is regulated under 21 CFR 864.4010 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
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Basic Information
- Product Code
- KDY
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.