BIOTIS BIGGY AGAR & BIGGY SLANT
Device Facts
| Record ID | K843761 |
|---|---|
| Device Name | BIOTIS BIGGY AGAR & BIGGY SLANT |
| Applicant | Otisville Biotech, Inc. |
| Product Code | JSI · Microbiology |
| Decision Date | Oct 10, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
