Alinity 07P6201

GUDID 00380740130831

Alinity i CEA Calibrators

Abbott Ireland Diagnostics

Carcinoembryonic antigen (CEA) IVD, calibrator

• Primary Device ID: 00380740130831
• NIH Device Record Key: b7c092ae-8ccf-447a-9bf9-06856dd0bbbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity
• Version Model Number: 07P6201
• Catalog Number: 07P6201
• Company DUNS: 985307301
• Company Name: Abbott Ireland Diagnostics
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740130831 [Primary]

FDA Product Code

• DHX: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

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: 2019-01-31
• Device Publish Date: 2018-12-31

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