BIOSCAN REAGENT STRIPS
Device Facts
| Record ID | K943008 |
|---|---|
| Device Name | BIOSCAN REAGENT STRIPS |
| Applicant | Genesis Labs, Inc. |
| Product Code | JJB · Clinical Chemistry |
| Decision Date | Aug 8, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1115 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.
