aLF Reader 9002764

GUDID 04053228034469

photometric reader for scanning and interpretation of immunochromatographic assays

QIAGEN GmbH

Photometric immunoassay analyser IVD
Primary Device ID04053228034469
NIH Device Record Key4dbe3141-e266-4717-b64b-c3f75996bacc
Commercial Distribution StatusIn Commercial Distribution
Brand NameaLF Reader
Version Model Number1
Catalog Number9002764
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 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
GS104053228034469 [Primary]

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-23
Device Publish Date2019-04-15

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