EMIT URINE METHADONE ASSAY #3E319
Device Facts
| Record ID | K820900 |
|---|---|
| Device Name | EMIT URINE METHADONE ASSAY #3E319 |
| Applicant | Syva Co. |
| Product Code | DDE · Immunology |
| Decision Date | Apr 26, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.
