CZN · Iga, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CZN |
|---|---|
| Device Name | Iga, Fitc, 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 |
|---|---|---|---|---|
| K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | Helena Laboratories | Apr 12, 1989 | SESE |
| K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | Kallestad Laboratories, Inc. | Feb 26, 1986 | SESE |
| K841815 | OPTIMATE IGA TEST | Miles Laboratories, Inc. | Jun 1, 1984 | SESE |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Gelco Diagnostics, Inc. | Oct 31, 1983 | SESE |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Gelco Diagnostics, Inc. | Oct 28, 1983 | SESE |
| K831909 | RABBIT ANTISERUM TO HUMAN IGA | Dako Corp. | Jul 18, 1983 | SESE |
| K831607 | FIAX IGA TEST KIT | Intl. Diagnostic Technology | Jun 22, 1983 | SESE |
Top Applicants
- Gelco Diagnostics, Inc. — 2 clearances
- Dako Corp. — 1 clearance
- Helena Laboratories — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
