API 20E/UNISCEPT 20E
Device Facts
| Record ID | K924814 |
|---|---|
| Device Name | API 20E/UNISCEPT 20E |
| Applicant | Analytical Products, Inc. |
| Product Code | JSS · Microbiology |
| Decision Date | Mar 11, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
