DFZ · Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DFZ |
|---|---|
| Device Name | Igg (Gamma Chain Specific), 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Siemens Healthcare Diagnostics | Oct 21, 2009 | SESE |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | The Binding Site, Ltd. | Jun 17, 2002 | SESE |
| K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | Sanquin Blood Supply Foundation | May 14, 2002 | SESE |
| K955906 | BOEHRINGER MANNHEIM IGG ASSAY | Boehringer Mannheim Corp. | Feb 9, 1996 | SESE |
| K940422 | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | The Binding Site, Ltd. | May 27, 1994 | SESE |
| K812821 | H-103 IGG, H-104 IGA, H-105 IGM | Immulok, Inc. | Oct 26, 1981 | SESE |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Icl Scientific | Jan 26, 1981 | SESE |
| K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
Top Applicants
- The Binding Site, Ltd. — 2 clearances
- Kent Laboratories, Inc. — 2 clearances
- Siemens Healthcare Diagnostics — 1 clearance
- Sanquin Blood Supply Foundation — 1 clearance
- Immulok, Inc. — 1 clearance
