BECKMAN R.PR CONTROL SERUM SET
Device Facts
| Record ID | K812425 |
|---|---|
| Device Name | BECKMAN R.PR CONTROL SERUM SET |
| Applicant | Beckman Instruments, Inc. |
| Product Code | GMP · Microbiology |
| Decision Date | Sep 23, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.
