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Iga, Antigen, Antiserum, Control

FDA product code CZP · 54 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5510
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2020-06-26

CZP 2020-06-26

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

Applicant HORIBA ABX SAS

K number K193525

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CZP 2006-02-13

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT

Applicant Beckman Coulter, Inc.

K number K060130

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CZP 2004-03-10

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

Applicant Roche Diagnostics Corp.

K number K040435

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CZP 2003-02-13

N LATEX IGA

Applicant Dade Behring, Inc.

K number K024038

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CZP 2000-01-14

WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD

Applicant Wako Chemicals USA, Inc.

K number K993927

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CZP 1998-11-04

IGA

Applicant Abbott Laboratories

K number K983359

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CZP 1996-09-25

QUANTEX IGA

Applicant Instrumentation Laboratory CO

K number K962200

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CZP 1996-04-05

IGA IMMUNOTURBIDIMETRIC & CALIBRATOR

Applicant Randox Laboratories, Ltd.

K number K955794

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CZP 1996-02-09

BOEHRINGER MANNHEIM IGA ASSAY

Applicant Boehringer Mannheim Corp.

K number K955907

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CZP 1995-06-20

N LATEX IGA

Applicant Behring Diagnostics, Inc.

K number K952309

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CZP 1993-07-16

IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE

Applicant The Binding Site, Ltd.

K number K931806

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CZP 1992-06-16

IL TEST IMMUNOGLOBULIN A

Applicant Instrumentation Laboratory CO

K number K920014

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CZP 1990-02-27

TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046

Applicant Helena Laboratories

K number K900422

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CZP 1989-08-02

RAICHEM(TM) SPIA(TM) IGA REAGENTS

Applicant Reagents Applications, Inc.

K number K894418

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CZP 1989-02-15

SPQ(TM) ANTIBODY REAGENT SET II FOR IGA

Applicant Atlantic Antibodies

K number K890560

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CZP 1988-10-19

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

Applicant Orion Diagnostica, Inc.

K number K884040

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CZP 1988-09-22

TECHNICON DPA-1 IMMUNOGLOBULIN A

Applicant Technicon Instruments Corp.

K number K883492

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CZP 1988-03-29

WAKO(TM) IGA-HA DIRECT

Applicant Wako Chemicals USA, Inc.

K number K880803

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CZP 1987-10-13

IMMUNOGLOBULINS A

Applicant Unipath , Ltd.

K number K873869

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CZP 1987-06-12

QM300 IGA, ANTIGEN, ANTISERUM, CONTROL

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K871940

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CZP 1986-09-17

PRECIMAT (R) IGA, G, M

Applicant Boehringer Mannheim Corp.

K number K863352

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CZP 1986-09-04

TINA-QUANT(R) IGA

Applicant Boehringer Mannheim Corp.

K number K862763

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CZP 1986-08-27

TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K855046

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CZP 1986-08-19

DAKO ITA, IMMUNOGLOBULIN A (IGA)

Applicant Dako Corp.

K number K862183

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CZP 1986-04-25

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

Applicant Atlantic Antibodies

K number K861167

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CZP 1986-02-26

QUANTIMETRIC PLUS IGA REAGENT KIT

Applicant Kallestad Laboratories, Inc.

K number K855009

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CZP 1985-09-16

GILFORD IMMUNOGLOBULIN A REAGENT

Applicant Gilford

K number K853467

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CZP 1985-06-11

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM

Applicant Cooper Biomedical, Inc.

K number K851284

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CZP 1985-03-01

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A

Applicant Applications Lab

K number K850582

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CZP 1984-10-05

CORNING IMMUNOFIXATION SYS

Applicant Corning Medical & Scientific

K number K843614

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CZP 1984-08-28

TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG

Applicant Miles Laboratories, Inc.

K number K842468

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CZP 1984-08-02

AMER. HISTO-ID SYS PRIMARY IGA 2720-21

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K842330

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CZP 1983-10-31

FITC GOAT ANTI-HUMAN IGA A CHAIN

Applicant Gelco Diagnostics, Inc.

K number K832263

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CZP 1983-04-27

TIA-IGA REAGENT & CALIBRATOR SETS

Applicant Worthington Diagnostic Systems

K number K831102

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CZP 1982-12-30

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM

Applicant Syva Co.

K number K823567

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CZP 1982-12-30

IMMUNOGLOBULIN CONTROL

Applicant Syva Co.

K number K823566

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CZP 1982-08-03

IMMUNO DIAGNOSTICS ASSAY

Applicant Helena Laboratories

K number K822026

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CZP 1981-09-29

ACA IMMUNOGLOBULIN A/M CALIBRATORS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812633

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CZP 1981-09-29

ACA IMMUNOGLOBIN A TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812631

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CZP 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA

Applicant Dako Corp.

K number K812488

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CZP 1981-09-01

GELMAN IG-FIX KIT

Applicant Gelman Sciences, Inc.

K number K812253

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CZP 1981-05-08

AIM SYSTEM (FOR IGA)

Applicant Icl Scientific

K number K811125

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CZP 1981-01-26

AUTOMATED IMMUNOPRECIPITIN METHOD/IGA

Applicant Icl Scientific

K number K803274

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CZP 1980-06-30

J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY

Applicant J.T. Baker Chemical Co.

K number K801283

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CZP 1980-03-12

GEMENI IGA ASSAY

Applicant Electro-Nucleonics Laboratories, Inc.

K number K800449

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CZP 1980-02-19

IMMUNOGLOBULIN A REAGENT SYSTEM

Applicant Calbiochem-Behring Corp.

K number K800211

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CZP 1979-10-17

LANCER L-INA ANTI-IGA

Applicant Sherwood Medical Co.

K number K791401

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CZP 1979-04-12

ANTISERUM, HUMAN, IGA

Applicant Kent Laboratories, Inc.

K number K790703

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CZP 1979-04-03

A-GENT IMMUNOGLOBULINE TEST SYSTEM

Applicant Abbott Laboratories

K number K790479

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CZP 1978-02-03

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.

Applicant Gelman Instrument Co.

K number K772076

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CZP 1977-12-22

IMMUNOGLOBULIN A NEPHEL. ASSAY

Applicant Kallestad Laboratories, Inc.

K number K772251

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CZP 1977-09-15

IMMOCHEMISTRY SYSTEM

Applicant Beckman Instruments, Inc.

K number K771603

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CZP 1977-06-24

GOAT ANTISERUM IGA NEPHELOMETRIC

Applicant Kallestad Laboratories, Inc.

K number K770962

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CZP 1976-07-20

SERUM, IGA GOAT ANTI-HUMAN ACID

Applicant Oxford Laboratories, Inc.

K number K760146

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