TRYPTIC SOY BROTH MEDIA
Device Facts
| Record ID | K832620 |
|---|---|
| Device Name | TRYPTIC SOY BROTH MEDIA |
| Applicant | Carroll Biological Corp. |
| Product Code | JSC · Microbiology |
| Decision Date | Sep 12, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.
