CZP · Iga, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CZP |
|---|---|
| Device Name | Iga, 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 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | Jun 26, 2020 | SESE |
| K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | Beckman Coulter, Inc. | Feb 13, 2006 | SESE |
| K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | Roche Diagnostics Corp. | Mar 10, 2004 | SESE |
| K024038 | N LATEX IGA | Dade Behring, Inc. | Feb 13, 2003 | SESE |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | Jan 14, 2000 | SESE |
| K983359 | IGA | Abbott Laboratories | Nov 4, 1998 | SESE |
| K962200 | QUANTEX IGA | Instrumentation Laboratory CO | Sep 25, 1996 | SESE |
| K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | Apr 5, 1996 | SESE |
| K955907 | BOEHRINGER MANNHEIM IGA ASSAY | Boehringer Mannheim Corp. | Feb 9, 1996 | SESE |
| K952309 | N LATEX IGA | Behring Diagnostics, Inc. | Jun 20, 1995 | SESE |
| K931806 | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | Jul 16, 1993 | SESE |
| K920014 | IL TEST IMMUNOGLOBULIN A | Instrumentation Laboratory CO | Jun 16, 1992 | SESE |
| K900422 | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | Helena Laboratories | Feb 27, 1990 | SESE |
| K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | Aug 2, 1989 | SESE |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | Feb 15, 1989 | SESE |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Orion Diagnostica, Inc. | Oct 19, 1988 | SESE |
| K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A | Technicon Instruments Corp. | Sep 22, 1988 | SESE |
| K880803 | WAKO(TM) IGA-HA DIRECT | Wako Chemicals USA, Inc. | Mar 29, 1988 | SESE |
| K873869 | IMMUNOGLOBULINS A | Unipath , Ltd. | Oct 13, 1987 | SESE |
| K871940 | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL | Kallestad Diag, A Div. of Erbamont, Inc. | Jun 12, 1987 | SESE |
Top Applicants
- Kallestad Laboratories, Inc. — 3 clearances
- Boehringer Mannheim Corp. — 3 clearances
- Abbott Laboratories — 3 clearances
- Wako Chemicals USA, Inc. — 2 clearances
- Syva Co. — 2 clearances
