UROCYSTIN
Device Facts
| Record ID | K843382 |
|---|---|
| Device Name | UROCYSTIN |
| Applicant | Mission Pharmacal Co. |
| Product Code | JLC · Clinical Chemistry |
| Decision Date | Jan 8, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).
