Acrometrix WNVRNA

GUDID 00884883006270

Microgenics Corporation

West Nile virus nucleic acid IVD, control

• Primary Device ID: 00884883006270
• NIH Device Record Key: 4485c96d-3fd4-4725-bd04-97e80245f7e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acrometrix WNVRNA
• Version Model Number: 960500
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883006270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050061

FDA Product Code

• MYZ: Kit, Test (Donors), For Bloodborne Pathogen

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: 2018-10-18
• Device Publish Date: 2018-09-17

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• 00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays: 2021-05-13
• 00884883007765 - MAS SARS-CoV-2 IgG Positive Control: 2021-03-15
• 00884883007772 - MAS SARS-CoV-2 Negative Control: 2021-03-15
• 07613336154045 - OXY Oxycodone: 2020-09-17
• 00884883007505 - MAS Omni Infectious BSI Positive Control Panel: 2020-07-08