Alinity 09P521A

GUDID 00380740170264

Alinity c BenzQ Assay File

Abbott GmbH & Co. KG

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID00380740170264
NIH Device Record Keyb07ac550-7b16-4c14-9ac1-4900aa1e2070
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity
Version Model Number09P521A
Catalog Number09P521A
Company DUNS315786293
Company NameAbbott GmbH & Co. KG
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740170264 [Primary]
GS100380740170264 [Primary]
GS100380740170264 [Primary]

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), 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 Date2020-05-19
Device Publish Date2020-05-11

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