BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
Device Facts
| Record ID | K925183 |
|---|---|
| Device Name | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST |
| Applicant | Princeton Biomedix |
| Product Code | KTN · Immunology |
| Decision Date | Feb 23, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5640 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.
