HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
Device Facts
| Record ID | K960669 |
|---|---|
| Device Name | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS |
| Applicant | Morax |
| Product Code | CFF · Immunology |
| Decision Date | Jul 12, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
Regulatory Classification
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.
