Euroimmun Us Inc

FDA Filings

This page includes the latest FDA filings for Euroimmun Us Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Euroimmun Us Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3007118747
FEI Number3007118747
NameEUROIMMUN US INC.
Owner & OperatorEUROIMMUN US Inc.
Contact Address1 Bloomfield Ave.
Mountain Lakes NJ 07046 US
Official Correspondent
  • Daniel A Castellanos
  • 1-973-6561000-104
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1 Bloomfield Ave
Mountain Lakes, NJ 07046 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Euroimmun US, Inc.
EUROIMMUN Anti-BP230-CF ELISA (IgG)2020-09-17
EUROIMMUN US INC.
Anti-SARS-CoV-2 ELISA (IgG)2020-03-30
EUROIMMUN US INC.
Anti-SARS-CoV-2 ELISA (IgA)2020-03-30
EUROIMMUN US INC.
Anti-tissue Transglutaminase ELISA (IgG)2019-03-04
EUROIMMUN US INC.
Anti-tissue Transglutaminase ELISA (IgA)2019-03-04
Euroimmun US, Inc.
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)2019-02-28
EUROIMMUN US INC.
Mounting Medium2018-12-18
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 2 EUROPattern2018-05-25
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 13 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 32 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 25 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 22 EUROPattern2018-05-25
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 2 EUROPattern2018-05-25
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 13 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 32 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 25 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 22 EUROPattern2018-05-25
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 2 EUROPattern2018-05-25
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 13 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 32 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 25 EUROPattern2018-05-25
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 22 EUROPattern2018-05-25
Euroimmun US, Inc.
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern And EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern2018-05-24
EUROIMMUN US INC.
IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2018-04-25
EUROIMMUN US INC.
IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2018-04-25
EUROIMMUN US INC.
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern2018-04-25
EUROIMMUN US INC.
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern2018-04-25
Euroimmun US, Inc.
EUROIMMUN IFA: Crithidia Luciliae Sensitive (anti-dsDNA) EUROPattern2018-04-20
Euroimmun US, Inc.
EUROIMMUN IFA: Crithidia Luciliae (anti-dsDNA) EUROPattern2018-04-20
EUROIMMUN US INC.
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)2017-12-13
EUROIMMUN US, Inc.
Anti-Borrelia Burgdorferi US EUROLINE-WB (IgM)2017-12-10
EUROIMMUN US INC.
Anti-Strongyloides ELISA (IgG)2017-11-07
EUROIMMUN US INC.
MERGITE! 502017-11-07
EUROIMMUN US INC.
MERGITE! 102017-11-07
EUROIMMUN US INC.
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)2016-08-30
EUROIMMUN US INC.
Anti-West Nile Virus ELISA (IgM)2016-08-30
EUROIMMUN US INC.
Anti-West Nile Virus ELISA (IgG)2016-08-30
EUROIMMUN US, INC.
EUROIMMUN Anti-West Nile Virus ELISA (IgM)2016-08-12
EUROIMMUN US, INC.
EUROIMMUN Anti-West Nile Virus ELISA (IgG)2016-08-10
EUROIMMUN US INC.
Anti-Bordetella parapertussis IFA (IgG)2015-11-04
EUROIMMUN US INC.
Lyme ELISA (IgG/IgM)2015-05-04
EUROIMMUN US INC.
IFA 40: HEp-20-10 EUROPattern2015-05-04
EUROIMMUN US INC.
EUROPattern Suite (EUROPattern Microscope and Software)2015-05-04
EUROIMMUN US INC.
IFA 40: HEp-20-10 EUROPattern2015-05-04
EUROIMMUN US INC.
EUROPattern Suite (EUROPattern Microscope and Software)2015-05-04
EUROIMMUN US INC.
EUROLabOffice2015-05-04
EUROIMMUN US INC.
EUROLINE ENA ProfilePlus 4 (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA Profile 9 Ag (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA ProfilePlus 4 (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA Profile 9 Ag (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA ProfilePlus 4 (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA Profile 9 Ag (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA ProfilePlus 4 (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA Profile 9 Ag (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA ProfilePlus 4 (IgG)2014-12-12
EUROIMMUN US INC.
EUROLINE ENA Profile 9 Ag (IgG)2014-12-12
EUROIMMUN US INC.
Anti-Schistosoma mansoni IFA (IgG)2014-10-06
EUROIMMUN US INC.
Anti-Schistosoma ELISA (IgG)2014-10-06
EUROIMMUN US INC.
Anti-DNA-bound Lactoferrin IFA2014-10-06
EUROIMMUN US INC.
Anti-PLA2R ELISA (IgG)2014-06-30
EUROIMMUN US INC
EUROIMMUN ANTI-PLA2R ELISA (IGG)2014-06-27
EUROIMMUN US INC.
Anti-PLA2R IFA2014-06-03
EUROIMMUN US INC.
IFA 40: HEp-20-102014-03-25
EUROIMMUN US INC.
ANA Screen ELISA (IgG)2013-08-02
EUROIMMUN US INC.
25-OH Vitamin D ELISA2013-08-02
EUROIMMUN US INC.
Anti-ribosomal P Proteins ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-nRNP/Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Scl-70 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-B ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-A ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Jo-1 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Centromeres ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-ribosomal P Proteins ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-nRNP/Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Scl-70 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-B ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-A ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Jo-1 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Centromeres ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-ribosomal P Proteins ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-nRNP/Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Scl-70 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-B ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-A ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Jo-1 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Centromeres ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-ribosomal P Proteins ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-nRNP/Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Scl-70 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-B ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-A ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Jo-1 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Centromeres ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-ribosomal P Proteins ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-nRNP/Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Sm ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Scl-70 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-B ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-SS-A ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Jo-1 ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Anti-Centromeres ELISA (IgG)2013-08-02
EUROIMMUN US INC.
Sprinter XL (model 240 samples, IFA/ELISA)2013-05-17
EUROIMMUN US INC.
Sprinter XL (model 240 samples, IFA/ELISA incl. Incubator)2013-05-17
EUROIMMUN US INC.
Sprinter XL (model 160 samples, IFA/ELISA)2013-05-17
EUROIMMUN US INC.
Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator)2013-05-17
EUROIMMUN US INC.
IF Sprinter (model IFA/ELISA)2013-05-17
EUROIMMUN US INC.
IF Sprinter (model IFA/ELISA with ReSa-Trax)2013-05-17
EUROIMMUN US INC.
EUROLabWorkstation ELISA2013-05-17
EUROIMMUN US INC.
EUROIMMUN Analyzer I2013-05-17
EUROIMMUN US INC.
EUROIMMUN Analyzer I-2P2013-05-17
EUROIMMUN US INC.
EUROBlotOne2013-05-17
EUROIMMUN US INC.
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)2013-04-16
EUROIMMUN US INC.
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)2013-04-16
EUROIMMUN US INC.
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)2013-04-16
EUROIMMUN US INC.
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)2013-04-16
EUROIMMUN US INC.
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)2013-04-16
EUROIMMUN US INC.
Anti-ENA Pool ELISA (IgG)2013-04-12
EUROIMMUN US INC.
Anti-LKM-1 ELISA (IgG)2012-09-18
EUROIMMUN US INC.
Anti-SLA/LP ELISA (IgG)2012-09-18
EUROIMMUN US INC.
EUROLineScan2011-10-28
EUROIMMUN US INC.
EUROIMMUN Immunoblot Washbuffer2011-10-10
EUROIMMUN US INC.
Anti-Glutamate receptor (type NMDA) IFA2010-11-19
EUROIMMUN US INC.
Anti-M2-3E ELISA (IgG)2010-11-19
EUROIMMUN US INC.
Anti-Desmoglein 3 ELISA (IgG)2010-11-19
EUROIMMUN US INC.
Anti-Desmoglein 1 ELISA (IgG)2010-11-19
EUROIMMUN US INC
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM2010-09-13
EUROIMMUN US INC
EUROIMMUN ANTI-M2-3E ELISA (IGG)2010-09-02
EUROIMMUN US INC
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)2010-09-02
EUROIMMUN US INC.
Anti-Candida albicans IFA (IgG)2009-10-27
EUROIMMUN US INC.
EUROStar III Plus2009-10-27
EUROIMMUN US INC.
EUROPicture2009-10-27
EUROIMMUN US INC.
Anti-Echo virus Type 7 IFA (IgG)2009-10-27
EUROIMMUN US INC.
EUROLINE Bordetella pertussis (IgG)2009-10-27
EUROIMMUN US INC.
Anti-Gliadin (GAF-3X) ELISA (IgG)2009-08-16
EUROIMMUN US INC
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)2009-08-07
EUROIMMUN US INC.
Anti-Gliadin (GAF-3X) ELISA (IgA)2009-07-31
EUROIMMUN US INC
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)2009-07-28
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 322009-07-16
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 222009-07-16
EUROIMMUN US INC.
EUROPLUS Granulocyte Mosaic 202009-07-16
EUROIMMUN US INC
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS2009-05-20
EUROIMMUN US INC.
Anti-dsDNA-NcX ELISA (IgG)2009-04-16
EUROIMMUN US INC
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)2009-04-15
EUROIMMUN US INC
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)2009-04-07
EUROIMMUN US INC.
Anti-PR3-hn-hr ELISA (IgG)2009-04-07
EUROIMMUN US INC.
Anti-BP180-NC16A-4X ELISA (IgG)2009-03-23
EUROIMMUN US INC
EUROIMMUN ANTI BP 180-4X ELISA (IGG)2009-03-16
EUROIMMUN US INC.
Anti-RSV ELISA (IgG)2008-10-20
EUROIMMUN US INC.
Sprinter XL (model 240 samples, IFA)2008-10-20
EUROIMMUN US INC.
Sprinter XL (model 240 samples, IFA incl. incubator)2008-10-20
EUROIMMUN US INC.
Sprinter XL (model 160 samples, IFA)2008-10-20
EUROIMMUN US INC.
Sprinter XL (model 160 samples, IFA incl. incubator)2008-10-20
EUROIMMUN US INC.
IF Sprinter (model IFA)2008-10-20
EUROIMMUN US INC.
IF Sprinter (model IFA with ReSa-Trax)2008-10-20
EUROIMMUN US INC.
EUROLabWorkstation IFA2008-10-20
EUROIMMUN US INC.
EUROBlotMaster2008-10-20
EUROIMMUN US INC.
EUROBlotMaster 442008-10-20
EUROIMMUN US INC.
IFA: Enterovirus Mosaic 1 (IgG)2008-10-20
EUROIMMUN US INC.
IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)2008-10-20
EUROIMMUN US INC.
IFA Mosaic: Coxsackie virus B Types (IgG)2008-10-20
EUROIMMUN US INC.
IFA Mosaic: Coxsackie virus A Types (IgG)2008-10-20
EUROIMMUN US INC.
IFA Mosaic: Coxsackie virus (IgG)2008-10-20
EUROIMMUN US INC.
Anti-Coxsackie virus Type B1 IFA (IgG)2008-10-20
EUROIMMUN US INC.
Anti-Coxsackie virus Type A7 IFA (IgG)2008-10-20
EUROIMMUN US INC.
Anti-CCP ELISA (IgG)2008-10-17
EUROIMMUN US INC.
ANA IFA: HEp-20-102008-10-17
EUROIMMUN US INC.
IFA: Oesophagus (Monkey) IgA2008-10-17
EUROIMMUN US INC.
IFA: Oesophagus (Monkey) IgA EUROPattern2008-10-17
EUROIMMUN US INC.
Anti-HSV-2 (gG2) ELISA (IgG)2008-10-17
EUROIMMUN US INC.
Anti-HSV-1 (gC1) ELISA (IgG)2008-10-17
EUROIMMUN US INC.
Anti-HSV-2 (gG2) ELISA (IgG)2008-10-17
EUROIMMUN US INC.
Anti-HSV-1 (gC1) ELISA (IgG)2008-10-17
EUROIMMUN US INC.
Anti-MPO ELISA (IgG)2008-10-17
EUROIMMUN US INC.
Anti-RSV IFA (IgG)2008-10-16
EUROIMMUN US INC.
Anti-Measles virus IFA (IgG)2008-10-16
EUROIMMUN US INC.
Anti-Mumps virus IFA (IgG)2008-10-16
EUROIMMUN US INC.
Anti-Echinococcus EUROLINE WB (IgG)2008-10-16
EUROIMMUN US INC.
Anti-Echinococcus ELISA (IgG)2008-10-16
EUROIMMUN US INC.
Anti-Echinococcus granulosus IFA (IgG)2008-10-16
EUROIMMUN US INC.
IFA: Granulocytes (HCHO)2008-10-15
EUROIMMUN US INC.
IFA: Granulocytes (EOH)2008-10-15
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 42008-10-15
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 22008-10-15
EUROIMMUN US INC.
IFA: Granulocyte Mosaic 132008-10-15
EUROIMMUN US INC.
Anti-Mycoplasma pneumoniae ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Mumps Virus ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Mumps Virus AT ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Measles Virus ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Brucella abortus ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Mycoplasma pneumoniae IFA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Mycoplasma hominis IFA (IgG)2008-10-15
EUROIMMUN US INC.
IFA Mosaic: Parainfluenza virus Types 1-4 (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Parainfluenza Viruses Pool ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Mosaic Bordetella pertussis / Bordetella parapertussis IFA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Bordetella pertussis IFA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Bordetella parapertussis IFA (IgG)2008-10-15
EUROIMMUN US INC.
IFA Mosaic: Influenza Virus Type A / Type B (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Influenza Virus Type B IFA (igG)2008-10-15
EUROIMMUN US INC.
Anti-Influenza Virus Type A IFA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Influenza B Virus ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Influenza A Virus ELISA (IgG)2008-10-15
EUROIMMUN US INC.
Anti-Adenovirus ELISA (IgG)2008-09-04
EUROIMMUN US INC.
Anti-Legionella pneumophila ELISA (IgG)2008-06-06
EUROIMMUN US INC.
IFA: Legionella Mosaic 4 (IgG)2008-06-06
EUROIMMUN US INC.
Anti-Adenovirus IFA (IgG)2008-06-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019121055142Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODE 940130003 PKG
2019100924717Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODE 940130004 PKG
2019092557535Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODE 940130004 PKG
2019092456446Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODE 940130004 PKG
2019072053953Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODES 94013000 SCAC SSLL AMS REF. NYC2570484 PKG
2019071850079Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCHAIRS HS CODES 94013000 SCAC SSLL AMS REF. NYC2570484 PKG
2019033035402Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyFILE CABINET AS PER INVOICE NO. 4190217 HS CODE 940330 HBL BANQBRE3809463 NOT STACKABLE DEST. NEW YORK .1 CAS
2018092425366Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPAINTINGS AS PER INVOICE NO. 5518031136 HS CODE 491191 HBL BANQBRE3640021 NOT STACKABLE DEST. NEW YORK .1 CAS

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