Lambda, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting the lambda light chain of immunoglobulins using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based quantification of this immunoglobulin component used in plasma cell dyscrasia evaluation. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DES, regulated under 21 CFR 866.5550, within the Immunology specialty.
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Basic Information
- Product Code
- DES
- 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.