JHR · Radioimmunoassay, Immunoglobulins (D, E)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | JHR |
|---|---|
| Device Name | Radioimmunoassay, Immunoglobulins (D, E) |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061970 | ELECSYS IGE II IMMUNOASSAY | Roche Diagnostics | Aug 31, 2006 | SESE |
| K984326 | ELECYS IGE ASSAY | Boehringer Mannheim Corp. | Feb 8, 1999 | SESE |
| K960067 | IMMILITE TOTAL IGE | Diagnostic Products Corp. | Feb 14, 1996 | SESE |
| K931703 | IMMULITE TOTAL IGE | Diagnostic Products Corp. | Aug 16, 1993 | SESE |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | Jul 31, 1990 | SESE |
| K901859 | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | Diagnostic Products Corp. | May 3, 1990 | SESE |
| K882616 | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | Pharmacia, Inc. | Aug 4, 1988 | SESE |
| K873077 | PHARMACIA IGE EIA | Pharmacia, Inc. | Oct 20, 1987 | SESE |
| K840103 | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | Techniclone Intl. | Feb 10, 1984 | SESE |
Top Applicants
- Diagnostic Products Corp. — 3 clearances
- Pharmacia, Inc. — 2 clearances
- Ventrex Laboratories, Inc. — 1 clearance
- Techniclone Intl. — 1 clearance
- Roche Diagnostics — 1 clearance
