DDN · Beta-2-Glycoprotein I, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5430 · Class 1
Overview
| Product Code | DDN |
|---|---|
| Device Name | Beta-2-Glycoprotein I, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5430 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
