BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
Device Facts
| Record ID | K001022 |
|---|---|
| Device Name | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 |
| Applicant | Biocheck, Inc. |
| Product Code | JZG · Immunology |
| Decision Date | Sep 26, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
