DCJ · Beta-Globulin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5160 · Class 1
Overview
| Product Code | DCJ |
|---|---|
| Device Name | Beta-Globulin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5160 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891093 | ACA (R) DIGITOXIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Apr 26, 1989 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
