DGK · Igg, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DGK |
|---|---|
| Device Name | Igg, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831908 | RABBIT ANTISERUM TO HUMAN IGG | Dako Corp. | Jul 18, 1983 | SESE |
| K831609 | FIAX IGG TEST KIT | Intl. Diagnostic Technology | Jun 17, 1983 | SESE |
Top Applicants
- Dako Corp. — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
