EUROPattern Microscope 1.5

GUDID 04049016100560

EUROIMMUN Medizinische Labordiagnostika AG

Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Primary Device ID04049016100560
NIH Device Record Key6d9db651-344f-4681-a26d-859df7a231fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUROPattern Microscope 1.5
Version Model NumberYG 0333-0101
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104049016100560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

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04049016144595 - IFA: Oesophagus (Monkey) IgA EUROPattern2024-05-27
04049016125228 - EUROArrayScanner2023-11-28
04049016159704 - EUROPLUS Granulocyte Mosaic 322023-10-13
04049016159018 - UNIQO 1602023-09-28
04049016152989 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2023-07-13
04049016069355 - Adjustment solution2023-06-02

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