DAA · Igg, Peroxidase, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DAA |
|---|---|
| Device Name | Igg, Peroxidase, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832675 | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | Sep 12, 1983 | SESE |
| K831927 | ANTINUCLEAR ANTIBODY TEST KIT | Breit Laboratories, Inc. | Jul 18, 1983 | SESE |
| K830005 | IP SPECIFIC G | Diagnostic Reagent Tech. | Jun 2, 1983 | SESE |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | Oct 22, 1982 | SESE |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | Oct 17, 1979 | SESE |
Top Applicants
- Clinical Sciences, Inc. — 3 clearances
- Breit Laboratories, Inc. — 1 clearance
- Diagnostic Reagent Tech. — 1 clearance
