Reagent, Immunoassay, Igg
The IgG Immunoassay Reagent is an in vitro diagnostic reagent used to measure immunoglobulin G (IgG) concentrations in patient serum or plasma, supporting assessment of immune status, antibody deficiencies, and certain inflammatory conditions. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket notification required. The product code is KTO, regulated under 21 CFR 866.5530, in the Immunology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KTO
- Device Class
- FDA class 1
- Regulation Number
- 866.5530
- 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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.