TRICHINELLA SEROLOGY MICROTITER ELISA
Device Facts
| Record ID | K904613 |
|---|---|
| Device Name | TRICHINELLA SEROLOGY MICROTITER ELISA |
| Applicant | Lmd Laboratories |
| Product Code | GPG · Microbiology |
| Decision Date | Mar 21, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genus Trichinella and provides epidemiological information on trichinosis. Trichinosis is caused by ingestion of undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.
