FAST MUCOPROTEINS
Device Facts
| Record ID | K863070 |
|---|---|
| Device Name | FAST MUCOPROTEINS |
| Applicant | J. D. Assoc. |
| Product Code | JQN · Clinical Chemistry |
| Decision Date | Sep 11, 1986 |
| 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.
