CZP · Class II · 21 CFR 866.5510

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

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

54
Total
54
Cleared
48d
Avg days
1976
Since

FDA 510(k) Cleared Iga, Antigen, Antiserum, Control Devices (Product Code CZP)

54 devices
1–24 of 54
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525
HORIBA ABX SAS
Immunology · 190d
Cleared Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130
Beckman Coulter, Inc.
Immunology · 26d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435
Roche Diagnostics Corp.
Immunology · 20d
Cleared Feb 13, 2003
N LATEX IGA
K024038
Dade Behring, Inc.
Immunology · 69d
Cleared Jan 14, 2000
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
K993927
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Nov 04, 1998
IGA
K983359
Abbott Laboratories
Immunology · 41d
Cleared Sep 25, 1996
QUANTEX IGA
K962200
Instrumentation Laboratory CO
Immunology · 110d
Cleared Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Jun 20, 1995
N LATEX IGA
K952309
Behring Diagnostics, Inc.
Immunology · 34d
Cleared Jul 16, 1993
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
K931806
The Binding Site, Ltd.
Immunology · 95d
Cleared Jun 16, 1992
IL TEST IMMUNOGLOBULIN A
K920014
Instrumentation Laboratory CO
Immunology · 166d
Cleared Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422
Helena Laboratories
Immunology · 28d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418
Reagents Applications, Inc.
Chemistry · 16d
Cleared Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
K884040
Orion Diagnostica, Inc.
Immunology · 23d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492
Technicon Instruments Corp.
Immunology · 37d
Cleared Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
K880803
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Oct 13, 1987
IMMUNOGLOBULINS A
K873869
Unipath , Ltd.
Immunology · 50d
Cleared Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Sep 17, 1986
PRECIMAT (R) IGA, G, M
K863352
Boehringer Mannheim Corp.
Immunology · 19d
Cleared Sep 04, 1986
TINA-QUANT(R) IGA
K862763
Boehringer Mannheim Corp.
Immunology · 44d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046
Abbott Laboratories
Immunology · 253d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183
Dako Corp.
Immunology · 71d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009
Kallestad Laboratories, Inc.
Immunology · 72d

About Product Code CZP - Regulatory Context