ELVI MUCAPROTEINS
Device Facts
| Record ID | K792554 |
|---|---|
| Device Name | ELVI MUCAPROTEINS |
| Applicant | Volu Sol Medical Industries |
| Product Code | JQN · Clinical Chemistry |
| Decision Date | Jan 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1505 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.
