CZP · Class II · 21 CFR 866.5510

FDA Product Code CZP: Iga, Antigen, Antiserum, Control

Leading manufacturers include Kallestad Laboratories, Inc., Abbott Laboratories and Boehringer Mannheim Corp..

54
Total
54
Cleared
48d
Avg days
1976
Since
54 devices
25–48 of 54
Cleared Apr 25, 1986
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K861167
Atlantic Antibodies
Immunology · 28d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Jun 11, 1985
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
K851284
Cooper Biomedical, Inc.
Immunology · 71d
Cleared Oct 05, 1984
CORNING IMMUNOFIXATION SYS
K843614
Corning Medical & Scientific
Chemistry · 21d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Apr 27, 1983
TIA-IGA REAGENT & CALIBRATOR SETS
K831102
Worthington Diagnostic Systems
Immunology · 22d
Cleared Dec 30, 1982
IMMUNOGLOBULIN CONTROL
K823566
Syva Co.
Chemistry · 27d
Cleared Dec 30, 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567
Syva Co.
Immunology · 27d
Cleared Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
K822026
Helena Laboratories
Chemistry · 22d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN A TEST PACK
K812631
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA
K812488
Dako Corp.
Immunology · 23d
Cleared Sep 01, 1981
GELMAN IG-FIX KIT
K812253
Gelman Sciences, Inc.
Chemistry · 21d
Cleared May 08, 1981
AIM SYSTEM (FOR IGA)
K811125
Icl Scientific
Immunology · 14d
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274
Icl Scientific
Immunology · 28d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Mar 12, 1980
GEMENI IGA ASSAY
K800449
Electro-Nucleonics Laboratories, Inc.
Immunology · 12d
Cleared Feb 19, 1980
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGA
K791401
Sherwood Medical Co.
Immunology · 79d
Cleared Apr 12, 1979
ANTISERUM, HUMAN, IGA
K790703
Kent Laboratories, Inc.
Immunology
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479
Abbott Laboratories
Chemistry · 26d
Cleared Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Sep 15, 1977
IMMOCHEMISTRY SYSTEM
K771603
Beckman Instruments, Inc.
Immunology · 24d