CYSTINE TRYPTIC MEDIUM W/ MALTOSE
Device Facts
| Record ID | K880112 |
|---|---|
| Device Name | CYSTINE TRYPTIC MEDIUM W/ MALTOSE |
| Applicant | Hardy Media |
| Product Code | JSF · Microbiology |
| Decision Date | Mar 30, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.
