DEW · Igg, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DEW |
|---|---|
| Device Name | Igg, 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 (20 of 76)
Showing 20 most recent of 76 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050113 | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | Feb 8, 2005 | SESE |
| K040434 | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | Mar 10, 2004 | SESE |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | Mar 15, 2001 | SESE |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | Jan 18, 2000 | SESE |
| K993281 | K-ASSAY IGG | Kamiya Biomedical Co. | Nov 9, 1999 | SESE |
| K983221 | IGG | Abbott Laboratories | Nov 4, 1998 | SESE |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | Mar 6, 1997 | SESE |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | Mar 6, 1997 | SESE |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | Beckman Instruments, Inc. | Feb 10, 1997 | SESE |
| K962202 | QUANTEX IGG | Instrumentation Laboratory CO | Sep 26, 1996 | SESE |
| K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | Apr 5, 1996 | SESE |
| K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | Beckman Instruments, Inc. | May 15, 1995 | SESE |
| K943997 | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | Oct 3, 1994 | SESE |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | Apr 21, 1994 | SESE |
| K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | Sep 8, 1993 | SESE |
| K924197 | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | Dec 15, 1992 | SESE |
| K921575 | IGG SUCLASS EIA | Virotech Diagnostika | May 28, 1992 | SESE |
| K911610 | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | Janssen Research Foundation | Jun 12, 1991 | SESE |
| K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Apr 26, 1990 | SESE |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Coulter Immunology | Aug 3, 1989 | SESE |
Top Applicants
- Kent Laboratories, Inc. — 5 clearances
- Beckman Instruments, Inc. — 4 clearances
- Dako Corp. — 4 clearances
- Icl Scientific — 4 clearances
- Abbott Laboratories — 3 clearances
