Alinity 01R091A

GUDID 00380740151768

Alinity c B2M Assay File

Abbott GmbH & Co. KG

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00380740151768
• NIH Device Record Key: 06341151-0515-41c8-9b17-e986b6213581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity
• Version Model Number: 01R091A
• Catalog Number: 01R091A
• Company DUNS: 315786293
• Company Name: Abbott GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740151768 [Primary]

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-04

On-Brand Devices [Alinity]

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• 00380740151768: Alinity c B2M Assay File
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• 00380740151430: Alinity i Anti-TPO Assay File
• 00380740151423: Alinity i Anti-Tg Assay File
• 00380740151416: Alinity i Anti-CCP Assay File
• 00380740151393: Alinity i SHBG Reagent Kit
• 00380740151386: Alinity i SHBG Controls
• 00380740151379: Alinity i SHBG Calibrators
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• 00380740151355: Alinity i Anti-CCP Controls
• 00380740151348: Alinity i Anti-CCP Calibrators
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