LYOPHILIZED MICROORGANISMS
Device Facts
| Record ID | K831653 |
|---|---|
| Device Name | LYOPHILIZED MICROORGANISMS |
| Applicant | Austin Biological Laboratories |
| Product Code | JTR · Microbiology |
| Decision Date | Jul 28, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2480 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
