Indirect Copper Assay, Ceruloplasmin
Indirect Copper Assay for Ceruloplasmin is an immunology test system that estimates ceruloplasmin levels by indirectly measuring copper content, used in the evaluation of copper metabolism disorders such as Wilson's disease and Menkes syndrome. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JFR, regulated under 21 CFR 866.5210, within the Immunology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JFR
- Device Class
- FDA class 2
- Regulation Number
- 866.5210
- Medical Specialty
- Immunology
- Review Panel
- IM
- 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 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.