AMH Control

GUDID 17350066140579

Fujirebio Diagnostics AB

Anti-Mullerian hormone (AMH) IVD, control

• Primary Device ID: 17350066140579
• NIH Device Record Key: 3d55136a-f9f3-4313-b237-d6a99c669abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMH Control
• Version Model Number: 660-20
• Company DUNS: 357159631
• Company Name: Fujirebio Diagnostics AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: +4631857030
• Email: info@fdab.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350066140579 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2019-05-03
• Device Publish Date: 2019-04-25

Devices Manufactured by Fujirebio Diagnostics AB

• 17350066140579 - AMH Control: 2019-05-03
• 17350066140579 - AMH Control: 2019-05-03
• 17350066140135 - CYFRA 21-1 EIA: 2019-04-09
• 17350066140524 - Mesothelin Control: 2019-04-05
• 17350066140531 - Lung Marker Control: 2019-04-05
• 17350066140043 - Tumor Marker Control: 2018-07-06
• 17350066140326 - HE4 EIA: 2018-07-06