BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
Device Facts
| Record ID | K961024 |
|---|---|
| Device Name | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB |
| Applicant | Princeton BioMeditech Corp. |
| Product Code | KTN · Immunology |
| Decision Date | Feb 4, 1997 |
| 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.
