DIFFERENTIAL I.M. SCREENING TEST
Device Facts
| Record ID | K873297 |
|---|---|
| Device Name | DIFFERENTIAL I.M. SCREENING TEST |
| Applicant | Sclavo, Inc. |
| Product Code | KTN · Immunology |
| Decision Date | Dec 14, 1987 |
| 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.
