DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
Device Facts
| Record ID | K010159 |
|---|---|
| Device Name | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
| Applicant | Dade Microscan, Inc. |
| Product Code | LTT · Microbiology |
| Decision Date | Jul 27, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
