DEX · Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5420 · Class 1
Overview
| Product Code | DEX |
|---|---|
| Device Name | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5420 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823765 | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | Dec 30, 1982 | SESE |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | J.T. Baker Chemical Co. | Sep 26, 1980 | SESE |
| K791341 | HUMAN ALPHA, ACID GLYCOPROTEIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE |
| K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | Icl Scientific | Aug 14, 1978 | SESE |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | Jul 20, 1976 | SESE |
Top Applicants
- Oxford Laboratories, Inc. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance
- Icl Scientific — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
