FDA.reportPublic FDA data

EUROPattern Microscope

Primary DI
04049016100560
Brand
EUROPattern Microscope
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
YG 0333-0101
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141827000EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWAREEuroimmun Us, Inc.2015-04-17DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016100560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016100560040490161005604049016100560

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, semi-automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340239dIFine ANCA ClassifierVISIA LAB SRLPIV2025-06-27
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLPIV2024-11-08
08059304340222dIFine DNA ClassifierVISIA LAB SRLPIV2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2024-09-11
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2023-07-05
04250289512541HELIOS® AUTOMATED IFA SYSTEMAesku.Diagnostics GmbH & Co. KGPIV2023-06-25
00845533001861ZEUS NTx SerumZEUS SCIENTIFIC, INC.PIV2023-04-18
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGPIV2022-12-08
08059304340109dIFine Automated Microscope VISIA LAB SRLPIV2022-09-07
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.PIV2021-03-31
04049016107057IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2020-08-28
04260186125096HELIOSAesku.Systems GmbH & Co. KGPIV2020-03-02
M74900IN2201Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
M74900IN1101Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
M749IN1101Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
M749IN2201Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108559IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108566IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108634IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108641IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108658IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108665IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108733EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108740EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108757EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04