THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
Device Facts
| Record ID | K942192 |
|---|---|
| Device Name | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | LER · Clinical Toxicology |
| Decision Date | Jul 13, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
