BK Virus Probe ASR 1067392

GUDID 04053228004431

QIAGEN GmbH

BK virus (BKV) nucleic acid IVD, reagent
Primary Device ID04053228004431
NIH Device Record Key20c124ec-36ca-4c86-9c4b-d6e8a2549168
Commercial Distribution StatusIn Commercial Distribution
Brand NameBK Virus Probe ASR
Version Model Number1
Catalog Number1067392
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
GS104053228004431 [Primary]

FDA Product Code

MVUReagents,Specific,Analyte

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

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