DGP · Ige, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DGP |
|---|---|
| Device Name | Ige, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931224 | VIDAS TOTAL IGE (IGE) ASSAY | Biomerieux Vitek, Inc. | May 20, 1993 | SESE |
| K863327 | IMMPULSE IGE ASSAY REAGENTS | Sclavo, Inc. | Dec 3, 1986 | SESE |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Allergenetics | Aug 28, 1984 | SESE |
| K842749 | FIAX TOTAL IGE TEST KIT | Intl. Diagnostic Technology | Aug 28, 1984 | SESE |
Top Applicants
- Sclavo, Inc. — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Allergenetics — 1 clearance
