COAGULASE PLASMA
Device Facts
| Record ID | K792235 |
|---|---|
| Device Name | COAGULASE PLASMA |
| Applicant | Remel Co. |
| Product Code | JTL · Microbiology |
| Decision Date | Dec 7, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused by these microorganisms.
