Alinity 03R7521

GUDID 00380740146269

Alinity i ROMA

Abbott GmbH

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00380740146269
• NIH Device Record Key: 0768e505-dfff-489e-8680-2c7a41d938c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity
• Version Model Number: 03R7521
• Catalog Number: 03R7521
• Company DUNS: 315786293
• Company Name: Abbott GmbH
• 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: false
• 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
• 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	00380740146269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151502

FDA Product Code

• ONX: Ovarian adnexal mass assessment score test system

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [Alinity]

• 00380740189105: Alinity c CrEnzU Assay File
• 00380740189099: Alinity c CrEnz Assay File
• 00380740179977: Alinity i Free T3 Assay File
• 00380740179960: Alinity i Total T3 Assay File
• 00380740154424: Alinity i HBsAgQu %N Assay File
• 00380740154417: Alinity i HBsAgQu C2 Assay File
• 00380740154400: Alinity i HBsAgQu C1 Assay File
• 00380740154394: Alinity i HBsAgQu Assay File
• 00380740146634: Alinity i POSTM_ROMA Assay File
• 00380740146627: Alinity i PREM_ROMA Assay File
• 00380740146269: Alinity i ROMA
• 00380740180164: Alinity c Phenytoin Assay File
• 00380740179199: Alinity c Lactic Acid Reagent Kit 1000 Tests
• 00380740193577: Alinity i Free T4 Assay File
• 00380740136628: Alinity i HAVAb IgM Reagent Kit 1000 Tests
• 00380740131371: Alinity i HAVAb IgG Reagent Kit 200 Tests
• 00380740194208: Alinity c BenzSQ Assay File
• 00380740194192: Alinity c BenzQ Assay File
• 00380740190118: Alinity c Carb Assay File
• 00380740194093: Alinity i COV 2IgGII Assay File
• 00380740195380: Alinity c A-ALT Assay File
• 00380740192464: Alinity i COV-2 IgM Assay File
• 00380740185787: Alinity i Active B12 Assay File
• 00380740154431: Alinity i HAV-IgG US Assay File
• 00380740142865: Alinity i Total PSA Assay File
• 00380740142858: Alinity i Free PSA Assay File
• 00380740200060: Alinity i Anti-CCP Assay File
• 00380740200053: Alinity c A1cWB Assay File
• 00380740200046: Alinity c %A1cWB Assay File
• 00380740200039: Alinity c A1cH Assay File
• 00380740200022: Alinity c %A1cH Assay File
• 00380740192723: Alinity c Uric2-U Assay File
• 00380740186418: Alinity c ALT2F Assay File
• 00380740186401: Alinity c ALT2 Assay File
• 00380740186395: Alinity c AST2F Assay File
• 00380740186388: Alinity c AST2 Assay File
• 00380740186364: Alinity c Uric2 Assay File
• 00380740186265: Alinity c GGT2 Asasy File
• 00380740186159: Alinity c TPRO2 Assay File
• 00380740193638: Alinity i STAT High Sensitivity Tropopnin-I
• 00380740199487: Alinity c Total Bilirubin Assay File
• 00380740189594: Alinity c Ammonia Assay File
• 00380740203177: Alinity i Toxo IgG Calibrators
• 00380740201975: Alinity i Toxo IgG
• 00380740174361: Alinity i Toxo IgG Reagent Kit (1000T)
• 00380740174354: Alinity i Toxo IgG Reagent Kit (200T)
• 00380740174347: Alinity i Toxo IgG Controls
• 00380740204112: Alinity c %A1cWB Assay File
• 00380740204105: Alinity c A1cWB Assay File
• 00380740202750: Alinity c ACETA Assay File