EUROArrayScanner

GUDID 04049016125228

EUROIMMUN Medizinische Labordiagnostika AG

Microscope slide digital imaging scanner IVD
Primary Device ID04049016125228
NIH Device Record Keye98d66b9-929f-4adf-8d4d-d9f57f27023e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUROArrayScanner
Version Model NumberYG 0602-0101
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 Datetrue
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
GS104049016125228 [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 Date2023-11-28
Device Publish Date2023-11-20

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

04049016159025 - EUROStar IV Plus2024-11-21
04049016151227 - FITC-labelled anti-human IgA2024-11-18
04049016151234 - FITC-labelled anti-human IgG 2024-11-18
04049016151562 - ELISA enzyme conjugate, anti-human IgA2024-11-18
04049016151593 - FITC-labelled anti-human IgA2024-11-18
04049016151609 - FITC-labelled anti-human IgG2024-11-18
04049016137894 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2024-09-19
04049016151999 - Mounting medium (IFA)2024-07-25

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