DEN · Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5420 · Class 1
Overview
| Product Code | DEN |
|---|---|
| Device Name | Alpha-1-T-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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780325 | RID SYSTEM-HUMAN C-REACTIVE PROTEIN | Icl Scientific | Mar 17, 1978 | SESE |
| K771879 | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID | Hyland Therapeutic Div., Travenol Laboratories | Oct 19, 1977 | SESE |
Top Applicants
- Icl Scientific — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance
