STAPHAUREX ZL30
Device Facts
| Record ID | K851949 |
|---|---|
| Device Name | STAPHAUREX ZL30 |
| Applicant | Wellcome Diagnostics |
| Product Code | GTN · Microbiology |
| Decision Date | May 22, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).
