ABBOTT 07A1210

GUDID 00380740011628

XSYSTEMS TDx/TDx Flx Methotrexate II Controls

ABBOTT LABORATORIES

Methotrexate therapeutic drug monitoring IVD, control

• Primary Device ID: 00380740011628
• NIH Device Record Key: 660a082b-98e0-426e-a0d9-244679d2678d
• Commercial Distribution Discontinuation: 2017-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ABBOTT
• Version Model Number: 7A12-10
• Catalog Number: 07A1210
• Company DUNS: 079226220
• Company Name: ABBOTT LABORATORIES
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740011628 [Primary]

FDA Product Code

• LAO: Enzyme immunoassay, methotrexate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-27
• Device Publish Date: 2016-09-09

On-Brand Devices [ABBOTT]

• 00380740089535: ABBOTT ESA Chagas Assay Kit
• 00380740011635: XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack
• 00380740011628: XSYSTEMS TDx/TDx Flx Methotrexate II Controls
• 00380740011611: XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators