BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
Device Facts
| Record ID | K913229 |
|---|---|
| Device Name | BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN |
| Applicant | Baxter Diagnostics, Inc. |
| Product Code | LLH · Microbiology |
| Decision Date | Aug 29, 1991 |
| 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.
