Igd, Rhodamine, Antigen, Antiserum, Control
The IgD Rhodamine Antigen, Antiserum, and Control is a rhodamine-labeled fluorescent immunological reagent designed to detect IgD immunoglobulins, a class expressed primarily on the surface of mature B lymphocytes. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. The device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DGE
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- 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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.