BLASTOMYCES YEAST ANTIGEN
Device Facts
| Record ID | K760828 |
|---|---|
| Device Name | BLASTOMYCES YEAST ANTIGEN |
| Applicant | I M, Inc. |
| Product Code | JJJ · Clinical Chemistry |
| Decision Date | Nov 1, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.
