EUROArrayScan

GUDID 04049016126034

EUROIMMUN Medizinische Labordiagnostika AG

Laboratory instrument/analyser application software IVD
Primary Device ID04049016126034
NIH Device Record Keyf02dcf89-a3ad-49cd-a61b-94cd546716ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUROArrayScan
Version Model NumberYG 0621-0101
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016126034 [Primary]

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

04049016092599 - Anti-Glutamate receptor (type NMDA) IFA2025-12-29
04049016092605 - Anti-Glutamate receptor (type NMDA) IFA2025-12-29
04049016126034 - EUROArrayScan2025-12-29
04049016126034 - EUROArrayScan2025-12-29
04049016152101 - Reagent tray for incubation of slides2025-12-05
04049016152125 - Reagent tray for incubation of slides2025-12-05
04049016139232 - Free Triiodothyronine (FT3) ELISA2025-09-22
04049016151982 - Mounting medium (IIFT)2025-07-11
04049016152002 - Mounting medium (IIFT)2025-07-11

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