BIO-CHECK GRAM STAIN CONTROL
Device Facts
| Record ID | K821660 |
|---|---|
| Device Name | BIO-CHECK GRAM STAIN CONTROL |
| Applicant | American Scientific Products |
| Product Code | JTR · Microbiology |
| Decision Date | Jun 25, 1982 |
| 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.
