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).
Cleared Devices (54)
| 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 |
| K863352 | PRECIMAT (R) IGA, G, M | Boehringer Mannheim Corp. | Sep 17, 1986 | SESE |
| K862763 | TINA-QUANT(R) IGA | Boehringer Mannheim Corp. | Sep 4, 1986 | SESE |
| K855046 | TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT | Abbott Laboratories | Aug 27, 1986 | SESE |
| K862183 | DAKO ITA, IMMUNOGLOBULIN A (IGA) | Dako Corp. | Aug 19, 1986 | SESE |
| K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST | Atlantic Antibodies | Apr 25, 1986 | SESE |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | Kallestad Laboratories, Inc. | Feb 26, 1986 | SESE |
| K853467 | GILFORD IMMUNOGLOBULIN A REAGENT | Gilford | Sep 16, 1985 | SESE |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | Cooper Biomedical, Inc. | Jun 11, 1985 | SESE |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | Applications Lab | Mar 1, 1985 | SESE |
| K843614 | CORNING IMMUNOFIXATION SYS | Corning Medical & Scientific | Oct 5, 1984 | SESE |
| K842468 | TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG | Miles Laboratories, Inc. | Aug 28, 1984 | SESE |
| K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 | Bartels Immunodiagnostic Supplies, Inc. | Aug 2, 1984 | SESE |
| K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN | Gelco Diagnostics, Inc. | Oct 31, 1983 | SESE |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | Apr 27, 1983 | SESE |
| K823567 | IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM | Syva Co. | Dec 30, 1982 | SESE |
| K823566 | IMMUNOGLOBULIN CONTROL | Syva Co. | Dec 30, 1982 | SESE |
| K822026 | IMMUNO DIAGNOSTICS ASSAY | Helena Laboratories | Aug 3, 1982 | SESE |
| K812633 | ACA IMMUNOGLOBULIN A/M CALIBRATORS | E.I. Dupont DE Nemours & Co., Inc. | Sep 29, 1981 | SESE |
| K812631 | ACA IMMUNOGLOBIN A TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Sep 29, 1981 | SESE |
| K812488 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA | Dako Corp. | Sep 23, 1981 | SESE |
| K812253 | GELMAN IG-FIX KIT | Gelman Sciences, Inc. | Sep 1, 1981 | SESE |
| K811125 | AIM SYSTEM (FOR IGA) | Icl Scientific | May 8, 1981 | SESE |
| K803274 | AUTOMATED IMMUNOPRECIPITIN METHOD/IGA | Icl Scientific | Jan 26, 1981 | SESE |
| K801283 | J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | Jun 30, 1980 | SESE |
| K800449 | GEMENI IGA ASSAY | Electro-Nucleonics Laboratories, Inc. | Mar 12, 1980 | SESE |
| K800211 | IMMUNOGLOBULIN A REAGENT SYSTEM | Calbiochem-Behring Corp. | Feb 19, 1980 | SESE |
| K791401 | LANCER L-INA ANTI-IGA | Sherwood Medical Co. | Oct 17, 1979 | SESE |
| K790703 | ANTISERUM, HUMAN, IGA | Kent Laboratories, Inc. | Apr 12, 1979 | SESP |
| K790479 | A-GENT IMMUNOGLOBULINE TEST SYSTEM | Abbott Laboratories | Apr 3, 1979 | SESE |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | Gelman Instrument Co. | Feb 3, 1978 | SESE |
| K772251 | IMMUNOGLOBULIN A NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Dec 22, 1977 | SESE |
| K771603 | IMMOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | Sep 15, 1977 | SESE |
| K770962 | GOAT ANTISERUM IGA NEPHELOMETRIC | Kallestad Laboratories, Inc. | Jun 24, 1977 | SESE |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | Jul 20, 1976 | 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
