FDA.reportPublic FDA data

EUROLabOffice 4.0

Primary DI
04049016135210
Brand
EUROLabOffice 4.0
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
YG 0250-0101-7
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016135210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016135210040490161352104049016135210

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Regulatory Flags#

DUNS number
322209263
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04049016099031IFA 40: HEp-20-10FA 1522-2010-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B236CPP8030Clinisys CoPathPlusCliniSys, IncNVV2026-02-18
00860009458109SentinelVistapath Biosystems, Inc.NVV2023-05-01
B236VUE202210Sunquest VUECliniSys, IncNVV2022-12-19
B433CL0CyberLABASPYRA, LLCNVV2022-10-12
B236PWP13000Sunquest PowerPathCliniSys, IncNVV2022-04-14
B236CPP8000Sunquest CoPathPlusCliniSys, IncNVV2022-03-28
00859474006663SoftMediaSCC SOFT COMPUTERNVV2020-12-09
00859474006472SoftMediaSCC SOFT COMPUTERNVV2020-12-04
B236CPP7100Sunquest CoPathPlusCliniSys, IncNVV2020-11-12
B236PWP12000Sunquest PowerPathCliniSys, IncNVV2020-11-12
00859474006465SoftMediaSCC SOFT COMPUTERNVV2020-04-29
00859474006410SoftMediaSCC SOFT COMPUTERNVV2020-01-25
00859474006403SoftMediaSCC SOFT COMPUTERNVV2019-11-12
00859474006373SoftMediaSCC SOFT COMPUTERNVV2019-11-08
05060508820024ULTRA Laboratory Information SystemCIRDAN IMAGING LIMITEDNVV2019-10-08
08800019600121Imaging System HIS-5000UHuvitz Co., Ltd.NVV2019-05-10
00859474006366SoftMediaSCC SOFT COMPUTERNVV2019-03-15
00859474006342SoftMediaSCC SOFT COMPUTERNVV2018-12-08
00859474006298SoftMediaSCC SOFT COMPUTERNVV2018-07-21
00859474006250SoftMediaSCC SOFT COMPUTERNVV2018-04-04
00859474006212SoftMediaSCC SOFT COMPUTERNVV2018-01-19
00859474006182SoftMediaSCC SOFT COMPUTERNVV2017-10-26
00859474006144SoftMediaSCC SOFT COMPUTERNVV2017-07-15
00859474006106SoftMediaSCC SOFT COMPUTERNVV2017-05-13