Atlas FDA

CZP

54 FDA 510(k) clearances · Product code

28 daysmedian time to decision
105 days90th percentile
54clearances measured

FDA profile

Official device name
Iga, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525)HORIBA ABX SAS2020-06-26
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130)Beckman Coulter, Inc.2006-02-13
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435)Roche Diagnostics Corp.2004-03-10
N LATEX IGA (K024038)Dade Behring, Inc.2003-02-13
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927)Wako Chemicals USA, Inc.2000-01-14
IGA (K983359)Abbott Laboratories1998-11-04
QUANTEX IGA (K962200)Instrumentation Laboratory CO1996-09-25
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (K955794)Randox Laboratories, Ltd.1996-04-05
BOEHRINGER MANNHEIM IGA ASSAY (K955907)Boehringer Mannheim Corp.1996-02-09
N LATEX IGA (K952309)Behring Diagnostics, Inc.1995-06-20
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806)The Binding Site, Ltd.1993-07-16
IL TEST IMMUNOGLOBULIN A (K920014)Instrumentation Laboratory CO1992-06-16
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 (K900422)Helena Laboratories1990-02-27
RAICHEM(TM) SPIA(TM) IGA REAGENTS (K894418)Reagents Applications, Inc.1989-08-02
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (K890560)Atlantic Antibodies1989-02-15
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (K884040)Orion Diagnostica, Inc.1988-10-19
TECHNICON DPA-1 IMMUNOGLOBULIN A (K883492)Technicon Instruments Corp.1988-09-22
WAKO(TM) IGA-HA DIRECT (K880803)Wako Chemicals USA, Inc.1988-03-29
IMMUNOGLOBULINS A (K873869)Unipath , Ltd.1987-10-13
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL (K871940)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
PRECIMAT (R) IGA, G, M (K863352)Boehringer Mannheim Corp.1986-09-17
TINA-QUANT(R) IGA (K862763)Boehringer Mannheim Corp.1986-09-04
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT (K855046)Abbott Laboratories1986-08-27
DAKO ITA, IMMUNOGLOBULIN A (IGA) (K862183)Dako Corp.1986-08-19
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST (K861167)Atlantic Antibodies1986-04-25
QUANTIMETRIC PLUS IGA REAGENT KIT (K855009)Kallestad Laboratories, Inc.1986-02-26
GILFORD IMMUNOGLOBULIN A REAGENT (K853467)Gilford1985-09-16
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (K851284)Cooper Biomedical, Inc.1985-06-11
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (K850582)Applications Lab1985-03-01
CORNING IMMUNOFIXATION SYS (K843614)Corning Medical & Scientific1984-10-05
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG (K842468)Miles Laboratories, Inc.1984-08-28
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 (K842330)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
FITC GOAT ANTI-HUMAN IGA A CHAIN (K832263)Gelco Diagnostics, Inc.1983-10-31
TIA-IGA REAGENT & CALIBRATOR SETS (K831102)Worthington Diagnostic Systems1983-04-27
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM (K823567)Syva Co.1982-12-30
IMMUNOGLOBULIN CONTROL (K823566)Syva Co.1982-12-30
IMMUNO DIAGNOSTICS ASSAY (K822026)Helena Laboratories1982-08-03
ACA IMMUNOGLOBULIN A/M CALIBRATORS (K812633)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
ACA IMMUNOGLOBIN A TEST PACK (K812631)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA (K812488)Dako Corp.1981-09-23
GELMAN IG-FIX KIT (K812253)Gelman Sciences, Inc.1981-09-01
AIM SYSTEM (FOR IGA) (K811125)Icl Scientific1981-05-08
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA (K803274)Icl Scientific1981-01-26
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY (K801283)J.T. Baker Chemical Co.1980-06-30
GEMENI IGA ASSAY (K800449)Electro-Nucleonics Laboratories, Inc.1980-03-12
IMMUNOGLOBULIN A REAGENT SYSTEM (K800211)Calbiochem-Behring Corp.1980-02-19
LANCER L-INA ANTI-IGA (K791401)Sherwood Medical Co.1979-10-17
ANTISERUM, HUMAN, IGA (K790703)Kent Laboratories, Inc.1979-04-12
A-GENT IMMUNOGLOBULINE TEST SYSTEM (K790479)Abbott Laboratories1979-04-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (K772076)Gelman Instrument Co.1978-02-03
IMMUNOGLOBULIN A NEPHEL. ASSAY (K772251)Kallestad Laboratories, Inc.1977-12-22
IMMOCHEMISTRY SYSTEM (K771603)Beckman Instruments, Inc.1977-09-15
GOAT ANTISERUM IGA NEPHELOMETRIC (K770962)Kallestad Laboratories, Inc.1977-06-24
SERUM, IGA GOAT ANTI-HUMAN ACID (K760146)Oxford Laboratories, Inc.1976-07-20

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