EZ1 Advanced 9001411

GUDID 04053228010753

QIAGEN GmbH

Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD
Primary Device ID04053228010753
NIH Device Record Key932d2ae0-cf92-4868-9941-e0c2455cf32b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ1 Advanced
Version Model Number1
Catalog Number9001411
Company DUNS317103745
Company NameQIAGEN GmbH
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104053228010753 [Primary]

FDA Product Code

JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-15

Devices Manufactured by QIAGEN GmbH

04053228030072 - QIAsymphony® DSP Circulating DNA Kit2022-12-15
04053228031024 - RNeasy® DSP FFPE Kit2022-12-15
04053228045762 - QIAsymphony® DSP DNA Midi Kit2022-12-15
04053228045779 - QIAsymphony® DSP DNA Mini Kit2022-12-15
04053228045786 - QIAsymphony® DSP Virus/Pathogen Midi Kit2022-12-15
04053228045793 - QIAsymphony® DSP Virus/Pathogen Mini Kit2022-12-15
04053228045809 - EZ1® DSP Virus Kit2022-12-15
04053228045816 - EZ1® DSP DNA Blood Kit2022-12-15

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