Alinity 09P523A

GUDID 00380740170271

Alinity c BenzSQ Assay File

Abbott GmbH & Co. KG

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID00380740170271
NIH Device Record Key15bb8d9b-a60b-4a5e-857a-4c0358b5bbfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity
Version Model Number09P523A
Catalog Number09P523A
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


Device Identifiers

Device Issuing AgencyDevice ID
GS100380740170271 [Primary]
GS100380740170271 [Primary]

FDA Product Code



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

On-Brand Devices [Alinity]

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00380740151355Alinity i Anti-CCP Controls
00380740151348Alinity i Anti-CCP Calibrators
00380740151256Alinity c Prealbumin Calibrator Kit
00380740151089Alinity c Specific Proteins Multiconstituent Calibrator Kit
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00380740150815Alinity i Insulin Reagent Kit 200 Tests

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