TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002
Device Facts
| Record ID | K873060 |
|---|---|
| Device Name | TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002 |
| Applicant | Lakewood Biochemical Co., Inc. |
| Product Code | KZI · Microbiology |
| Decision Date | Aug 24, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2330 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
