CZP

Product Code: CZP

Products Classified as CZP

2883

Iga, Antigen, Antiserum, Control

Immunoglobulins A, G, M, D, And E Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2883

Iga, Antigen, Antiserum, Control

Immunoglobulins A, G, M, D, And E Immunological Test System.

FDA Consensus Standards

• Iga, Antigen, Antiserum, Control [14932]: 21 CFR §866.5510 🔎

Pre-market Notifications for CZP

K193525	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M	Horiba ABX SAS
K060130	IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT	BECKMAN COULTER, INC.
K040435	ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2	ROCHE DIAGNOSTICS CORP.
K024038	N LATEX IGA	DADE BEHRING, INC.
K993927	WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD	WAKO CHEMICALS, USA, INC.
K983359	IGA	ABBOTT LABORATORIES
K962200	QUANTEX IGA	INSTRUMENTATION LABORATORY CO.
K955794	IGA IMMUNOTURBIDIMETRIC & CALIBRATOR	RANDOX LABORATORIES, LTD.
K952309	N LATEX IGA	BEHRING DIAGNOSTICS, INC.
K931806	IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE	THE BINDING SITE, LTD.
K894418	RAICHEM(TM) SPIA(TM) IGA REAGENTS	REAGENTS APPLICATIONS, INC.
K890560	SPQ(TM) ANTIBODY REAGENT SET II FOR IGA	ATLANTIC ANTIBODIES
K884040	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A	ORION DIAGNOSTICA, INC.
K883492	TECHNICON DPA-1 IMMUNOGLOBULIN A	TECHNICON INSTRUMENTS CORP.
K880803	WAKO(TM) IGA-HA DIRECT	WAKO CHEMICALS, USA, INC.

Global Unique Device Identification Database

• 00380740019754: IGA, ANTIGEN, ANTISERUM, CONTROL
• 00380740000493: IGA, ANTIGEN, ANTISERUM, CONTROL
• 00842768007200: IGA, ANTIGEN, ANTISERUM, CONTROL
• 05700572000617: IGA, ANTIGEN, ANTISERUM, CONTROL
• 05055273203905: Iga, Antigen, Antiserum, Control
• 05055273203899: Iga, Antigen, Antiserum, Control
• 05055273203882: Iga, Antigen, Antiserum, Control
• 05055273203820: Iga, Antigen, Antiserum, Control
• 05051700010375: Iga, Antigen, Antiserum, Control
• B1761020: Iga, Antigen, Antiserum, Control
• 00380740153915: IGA, ANTIGEN, ANTISERUM, CONTROL
• 07613336121313: IGA, ANTIGEN, ANTISERUM, CONTROL
• 00630414285030: IGA, ANTIGEN, ANTISERUM, CONTROL
• 03610230007334: Iga, Antigen, Antiserum, Control
• 00380740171704: IGA, ANTIGEN, ANTISERUM, CONTROL

Maude Adverse Events

COBAS INTEGRA IGA GEN 2	ROCHE DIAGNOSTICS	2017-05-22
COBAS INTEGRA IGA GEN 2	ROCHE DIAGNOSTICS	2016-12-19
COBAS INTEGRA IGA GEN 2	ROCHE DIAGNOSTICS	2016-06-23
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2	ROCHE DIAGNOSTICS	2015-08-20
IGA REAGENT	BECKMAN COULTER INC.	2011-03-16