Ige, Fitc, Antigen, Antiserum, Control
The IgE FITC Antigen, Antiserum, and Control is a fluorescein isothiocyanate-conjugated reagent used to detect IgE immunoglobulins in fluorescence-based assays, supporting diagnostic evaluation of allergic disease and immune function. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DGP
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931224 | VIDAS TOTAL IGE (IGE) ASSAY | May 20, 1993 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K863327 | IMMPULSE IGE ASSAY REAGENTS | Dec 03, 1986 | Substantially Equivalent | Sclavo, Inc. |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Aug 28, 1984 | Substantially Equivalent | Allergenetics |
| K842749 | FIAX TOTAL IGE TEST KIT | Aug 28, 1984 | Substantially Equivalent | Intl. Diagnostic Technology |
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.