Euroimmun US Inc.
Mountain Lakes, NJ, US
EUROIMMUN US INC. appears in FDA device records in Mountain Lakes, NJ. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 37 510(k) clearances for Euroimmun US Inc. between 2006 and 2020. The busiest year on record is 2009, with 6. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 3 |
| 2009 | 6 |
| 2010 | 3 |
| 2012 | 2 |
| 2013 | 5 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | OEG | Substantially Equivalent | |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | MVM | Substantially Equivalent | |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern | MOB | Substantially Equivalent | |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | KTL | Substantially Equivalent | |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | KTL | Substantially Equivalent | |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | LSR | Substantially Equivalent | |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | LSR | Substantially Equivalent | |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | NOP | Substantially Equivalent | |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | NOP | Substantially Equivalent | |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | LSR | Substantially Equivalent | |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | DHN | Substantially Equivalent | |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | LKO | Substantially Equivalent | |
| K132195 | EUROIMMUN ANTI-PLA2R ELISA (IGG) | PGV | Substantially Equivalent | |
| DEN140002 | EUROIMMUN ANTI-PLA2R IFA | PGV | Unknown | |
| K131791 | IFA 40: HEP-20-10 | DHN | Substantially Equivalent | |
| K123660 | 25-OH VITAMIN D ELISA | MRG | Substantially Equivalent | |
| K131185 | ANA SCREEN ELISA (IGG) | LJM | Substantially Equivalent | |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | LKO | Substantially Equivalent | |
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | NIY | Substantially Equivalent | |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | LLL | Substantially Equivalent | |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | NBS | Substantially Equivalent | |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | NIY | Substantially Equivalent | |
| K100017 | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM | OSK | Substantially Equivalent | |
| K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | DBM | Substantially Equivalent | |
| K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) | NBO | Substantially Equivalent | |
| K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | MST | Substantially Equivalent | |
| K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | MST | Substantially Equivalent | |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | MOB | Substantially Equivalent | |
| K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | LRM | Substantially Equivalent | |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | MOB | Substantially Equivalent | |
| K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | OEG | Substantially Equivalent | |
| K070789 | EUROIMMUN ANTI-CCP ELISA | NHX | Substantially Equivalent | |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | MYF | Substantially Equivalent | |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | DHN | Substantially Equivalent | |
| K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | MVM | Substantially Equivalent | |
| K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | MOB | Substantially Equivalent | |
| K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | MOB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007118747 | 3007118747 | EUROIMMUN US INC. | 1 Bloomfield Ave, Mountain Lakes, NJ 07046 US | 2026 | and 68 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- MQAAnti-Ribosomal P Antibodies
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- MSTAntibodies, Gliadin
- GOXAntigen, B. Pertussis
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GOAAntisera, Cf, Adenovirus 1-33
- GQTAntisera, Cf, Parainfluenza Virus 1-4
- GSMAntisera, Fluorescent, Brucella Spp.
- GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- GNSAntisera, Hai, Influenza Virus A, B, C
- GPEAntisera, Positive Control, Echinococcus Spp.
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- JITCalibrator, Secondary
- JMMColumn Chromatography & Color Development, Hydroxyproline
- KEICondensers, Microscope
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- MDTElisa, Trichinella Spiralis
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LLLExtractable Antinuclear Antibody, Antigen And Control
- MJHLegionella, Spp., Elisa
- IBKMicroscope, Fluorescence/U.V.
- LEBMounting Media
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- CIBRadioimmunoassay, Angiotensin I And Renin
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CGIRadioimmunoassay, Estriol
- CGFRadioimmunoassay, Estrone
- CFLRadioimmunoassay, Human Growth Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JNGRadioimmunoassay, Pregnenolone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JMDRadioimmunoassay, Total Estrogens, Nonpregnancy
- CDPRadioimmunoassay, Total Triiodothyronine
- LSRReagent, Borrelia Serological Reagent
- MDJReagents, Cysticercosis
- MCERespiratory Syncytial Virus - Elisa
- JRQShaker/Stirrer
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JQWStation, Pipetting And Diluting, For Clinical Use
- MRGSystem, Test, Vitamin D
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain