TB SUSCEPTIBILITY QUADS I AND II
Device Facts
| Record ID | K920143 |
|---|---|
| Device Name | TB SUSCEPTIBILITY QUADS I AND II |
| Applicant | Remel Co. |
| Product Code | MJD · Microbiology |
| Decision Date | Jun 9, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.
