MJD · Culture Media, Antimycobacteria, Susceptibility Test
Microbiology · 21 CFR 866.1700 · Class 2
Overview
| Product Code | MJD |
|---|---|
| Device Name | Culture Media, Antimycobacteria, Susceptibility Test |
| Regulation | 21 CFR 866.1700 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920143 | TB SUSCEPTIBILITY QUADS I AND II | Remel Co. | Jun 9, 1992 | SESE |
| K840981 | NIACIN REAGENT STRIP | Remel Co. | Mar 23, 1984 | SESE |
| K823859 | MIDDLEBROOK 7H10 AGAR BASE-LOWPH | Gibco Laboratories Life Technologies, Inc. | Mar 8, 1983 | SESE |
Top Applicants
- Remel Co. — 2 clearances
- Gibco Laboratories Life Technologies, Inc. — 1 clearance
