Igg, Fitc, Antigen, Antiserum, Control
The IgG FITC Antigen, Antiserum, and Control is a fluorescein isothiocyanate-conjugated immunological reagent used in fluorescence assays to detect IgG immunoglobulins in clinical specimens, supporting diagnostic evaluation of immune status and autoimmune conditions. 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.
Basic Information
- Product Code
- DGK
- 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 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.