Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007118747

FEI Number

3007118747

Entity Name

EUROIMMUN US INC.

City/State/Country

Mountain Lakes, NJ, US

Establishment Address

1 Bloomfield Ave, Mountain Lakes, NJ 07046, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

EUROIMMUN US Inc. (Owner Number: 10025673)

Owner / Operator Contact Address

1 Bloomfield Ave., Mountain Lakes, NJ 07046, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IDS-iSYS CTX-I (Crosslaps) Control Set Anti-Influenza A Virus ELISA (IgG) IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifiers IDS iSYS 1,25 Dihydroxy Vitamin D Control Set Anti-dsDNA-NcX ELISA (IgG) Anti-West Nile Virus ELISA (IgG) Anti-Desmoglein 1 ELISA (IgG) Anti-Desmoglein 3 ELISA (IgG) Anti-Strongyloides ELISA (IgG) IDS-iSYS Insulin-like Growth Factor-I IGF-I Calibration Verifiers IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers IF Sprinter EUROBlotMaster EUROBlotMaster 44 Sprinter XL EUROLabWorkstation IFA UNIQO 160 IGF-I ELISA IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) IDS-iSYS Human Growth Hormone (hGH) Anti-Adenovirus ELISA (IgG) Anti-Gliadin (GAF-3X) ELISA (IgA) IDS-iSYS Intact PTH IDS-iSYS Intact PTH Control Set IDS-iSYS Intact PTH Calibration Verifiers EUROPLUS Granulocyte Mosaic 25 EUROPattern IFA: Granulocyte Mosaic 2 EUROPattern IFA: Granulocyte Mosaic 13 EUROPattern EUROPLUS Granulocyte Mosaic 22 EUROPattern EUROPLUS Granulocyte Mosaic 32 EUROPattern EUROPattern Classifier EUROIMMUN Analyzer I EUROIMMUN Analyzer I-2P Sprinter XL IF Sprinter EUROBlotOne EUROLabWorkstation ELISA System liquid concentrate Device Qualification Test Kit EUROLabWorkstation ELISA Device Qualification Test Kit EUROLabLiquidHandler IDS-iSYS System Liquid (Syst l) IDS-iSYS Trigger Set IDS-iSYS Cuvettes IDS-iSYS Wash Solution (Wash S) Device Qualification Test Kit EUROLabWorkstation IFA IDS Immunocleaner IDS-iSYS D-Sorb Solution Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P IDS Top Cap Set IDS-iSYS Cartridge Check System (CCS) Anti-Brucella abortus ELISA (IgG) Anti-Mumps Virus AT ELISA (IgG) Anti-Mumps Virus ELISA (IgG) ELISA wash buffer 10x conc. FITC-labelled anti-human IgG with propidium iodide for EUROPattern EUROIMMUN Immunoblot Washbuffer Adjustment solution Secondary reagents immunoblot (IgG) Secondary reagents immunoblot (IgM) ELISA enzyme conjugate, anti-human IgA EUROArray wash buffer set ELISA sample buffer PBS (IFA) FITC-labelled anti-human IgA Sample buffer (IFA) EUROSORB (IFA) Tween 20 (IFA) ELISA Stop solution ELISA chromogen/substrate solution FITC-labelled anti-human IgG with Evans Blue FITC-labelled anti-human IgA with Evans Blue WASH REAGENT 2 Anti-Measles Virus ELISA 2 (IgG) Anti-Measles Virus ELISA (IgG) IDS-iSYS Free Testosterone EUROPLUS Granulocyte Mosaic 22 EUROPLUS Granulocyte Mosaic 32 Pregnenolone ELISA IDS ACTH II ANA Screen ELISA (IgG) 1,25-Dihydroxy Vitamin D EIA IDS-iSYS Aldosterone IDS-iSYS Aldosterone Control Set IDS-iSYS Aldosterone Calibration Verifiers Anti-Influenza B Virus ELISA (IgG) Anti-MPO ELISA (IgG) IDS-iSYS XPrep Free Estriol ELISA IFA: Oesophagus (Monkey) IgA EUROPattern IFA: Oesophagus (Monkey) IgA Anti-SARS-CoV-2 ELISA (IgG) IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers IFA 40: HEp-20-10 Anti-PR3-hn-hr ELISA (IgG) Mounting medium (IIFT) 17-OH Progesterone ELISA Total Testosterone ELISA EUROLabOffice EUROLabOffice 4 25-Hydroxy Vitamin DS EIA IDS Prolactin IDS SHBG EUROPattern Microscope Live UNIQO 160 Anti-RSV ELISA (IgG) IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set Anti-PLA2R IFA Anti-BP230-CF ELISA (IgG) Total Estrogens ELISA IDS-iSYS Direct Renin Control Set IDS-iSYS Direct Renin IDS-iSYS Direct Renin Calibration Verifiers IFA: Granulocyte Mosaic 13 IFA: Granulocytes (HCHO) IFA: Granulocyte Mosaic 2 IFA: Granulocytes (EOH) Anti-Parainfluenza Viruses Pool ELISA (IgG) Anti-LKM-1 ELISA (IgG) EUROLineScan EUROStar III Plus EUROPicture EUROStar IV Plus EUROPattern Classifier IFA 40: HEp-20-10 EUROPattern EUROPattern Microscope Anti-tissue Transglutaminase ELISA (IgA) Anti-tissue Transglutaminase ELISA (IgG) IDS-iSYS Insulin like Growth Factor-I (IGF-I) IDS SDSpeed Calc IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) IFA Mosaic: Coxsackie virus B Types (IgG) IFA Mosaic: Coxsackie virus A Types (IgG) IFA Mosaic: Coxsackie virus (IgG) Anti-Borrelia burgdorferi US WESTERNBLOT (IgG) Anti-SLA/LP ELISA (IgG) ANA IFA: HEp-20-10 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROPattern Classifier 25-Hydroxy Vitamin D RIA IDS Intact PTHN IDS-iSYS 25 VitDS Control Set IDS-iSYS 25 VitDS Calibrator Set IDS-iSYS 25 VitDS IDS-iSYS Ostase® BAP Anti-Glutamate receptor (type NMDA) IFA EUROLINE-WB Anti-Echinococcus (IgG) Anti-Echinococcus ELISA (IgG) Anti-Echinococcus EUROLINE WB (IgG) Anti-Legionella pneumophila ELISA (IgG) IDS Cortisol Anti-nRNP/Sm ELISA (IgG) Anti-Scl-70 ELISA (IgG) Anti-ribosomal P Proteins ELISA (IgG) Anti-Sm ELISA (IgG) Anti-Jo-1 ELISA (IgG) Anti-Centromeres ELISA (IgG) Anti-SS-B ELISA (IgG) Anti-SS-A ELISA (IgG) Anti-CCP ELISA (IgG) Dehydroepiandrosterone Sulfate (DHEA-S) ELISA Dehydroepiandrosterone (DHEA) ELISA Serum CrossLaps® (CTX-I) ELISA Urine BETA CrossLaps® (CTX-I) ELISA Alpha CrossLaps® (CTX-I) EIA IDS-iSYS CTX-I (CrossLaps®) Urine CartiLaps ® (CTX-II) EIA Urine CrossLaps® (CTX-I) EIA Anti-M2-3E ELISA (IgG) Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) Anti-West Nile Virus ELISA (IgM) IDS iSYS Multi Discipline Automated System IDS i20 IDS-i10 Anti-Mycoplasma pneumoniae ELISA (IgG)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2008-10-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-04
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2009-04-16
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2016-08-30
NBO	Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)	Immunology	Class 2	866.5660	2010-11-19
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2017-11-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2008-10-20
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2023-08-04
GOA	Antisera, Cf, Adenovirus 1-33	Microbiology	Class 1	866.3020	2008-09-04
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2009-07-31
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2023-08-04
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2018-05-25
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2018-05-25
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2018-05-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-05-17
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	Class 2	866.3085	2008-10-15
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2008-10-15
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2011-10-10
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	2008-10-15
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2025-01-21
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2009-07-16
JNG	Radioimmunoassay, Pregnenolone	Clinical Chemistry	Class 1	862.1615	2021-03-11
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2023-11-10
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2013-08-02
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-04
CJM	Radioimmunoassay, Aldosterone	Clinical Chemistry	Class 2	862.1045	2023-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2008-10-15
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2008-10-17
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2023-08-04
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2021-10-25
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2008-10-17
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-11
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2014-03-25
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2009-04-07
LEB	Mounting Media	Pathology	Class 1	864.4010	2018-12-18
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2020-06-25
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2021-03-12
NVV	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	Clinical Chemistry	Class 1	862.2100	2015-05-04
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-04
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2024-08-02
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2023-08-04
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2022-08-19
MCE	Respiratory Syncytial Virus - Elisa	Microbiology	Class 1	866.3480	2008-10-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
PGV	Anti-Phospholipase A2 Receptor	Microbiology	Class 2	866.5780	2014-06-03
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230	Immunology	Class 2	866.5660	2020-09-23
JMD	Radioimmunoassay, Total Estrogens, Nonpregnancy	Clinical Chemistry	Class 1	862.1275	2020-06-25
CIB	Radioimmunoassay, Angiotensin I And Renin	Clinical Chemistry	Class 2	862.1085	2023-08-04
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2008-10-15
GQT	Antisera, Cf, Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2008-10-15
NBS	Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	Immunology	Class 2	866.5660	2012-09-18
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2011-10-28
KEI	Condensers, Microscope	Pathology	Class 1	864.3600	2009-10-27
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2015-05-04
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2015-05-04
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2019-03-04
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2023-08-04
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Microbiology	Class 1	866.3145	2008-10-20
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2016-08-30
NIY	Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis	Immunology	Class 2	866.5660	2012-09-18
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-10-17
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Immunology	Class 2	866.5100	2018-04-25
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2018-04-25
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-16
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2023-08-04
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2023-08-04
OSK	Anti-Glutamate Receptor (Type Nmda) Ifa	Immunology	Class 2	866.5660	2010-11-19
GPE	Antisera, Positive Control, Echinococcus Spp.	Microbiology	Class 1	866.3200	2008-10-16
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2008-06-06
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2023-08-04
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2013-08-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-08-02
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2013-08-02
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-08-02
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-08-02
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2008-10-17
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2020-06-25
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2023-08-04
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2010-11-19
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2017-12-13
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2016-08-30
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-08-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-08-04
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2008-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EUROIMMUN US Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007118747. Last updated year: 2026. Please use registration number 3007118747 when referencing this establishment in official correspondence.