21 CFR 866.5630 — System, Test, Beta-2-Microglobulin Immunological
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5630
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 | 53 |
Special Controls
JZG — System, Test, Beta-2-Microglobulin Immunological
*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.
eCFR
