LIAISON® XL Zika Capture IgM II

GUDID 08056771602624

Diasorin Inc.

Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08056771602624
• NIH Device Record Key: 27502a43-c99b-413f-8442-fac932691b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON® XL Zika Capture IgM II
• Version Model Number: 317150
• Company DUNS: 033429783
• Company Name: Diasorin Inc.
• 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: 651-439-9710
• Email: info@diasorin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056771602624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192046

FDA Product Code

• QFO: Zika Virus Serological Reagents

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: 2019-12-12
• Device Publish Date: 2019-12-04

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