PREMIER EHEC
Device Facts
| Record ID | K953362 |
|---|---|
| Device Name | PREMIER EHEC |
| Applicant | Meridian Diagnostics, Inc. |
| Product Code | GNA · Microbiology |
| Decision Date | Nov 14, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3255 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.
