Kappa, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting the kappa light chain of immunoglobulins using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based analysis. Kappa light chain testing is important in diagnosing and monitoring monoclonal gammopathies and plasma cell neoplasms. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEO, regulated under 21 CFR 866.5550, within the Immunology specialty.
Basic Information
- Product Code
- DEO
- Device Class
- FDA class 2
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.