DAH · Gamma Globulin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DAH |
|---|---|
| Device Name | Gamma Globulin, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Helena Laboratories | Apr 27, 1993 | SESE |
| K905149 | TITAN GEL | Helena Laboratories | Jan 3, 1991 | SESE |
| K901805 | REP(R) IMMUNOFIX | Helena Laboratories | Jun 6, 1990 | SESE |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Orion Diagnostica, Inc. | Oct 27, 1988 | SESE |
| K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G | Technicon Instruments Corp. | Sep 7, 1988 | SESE |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | Aug 27, 1986 | SESE |
| K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Dako Corp. | Aug 19, 1986 | SESE |
Top Applicants
- Helena Laboratories — 3 clearances
- Abbott Laboratories — 1 clearance
- Dako Corp. — 1 clearance
- Orion Diagnostica, Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance
