AcroMetrix BB NAT WNV Negative Control

GUDID 00884883005907

Microgenics Corporation

West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control

• Primary Device ID: 00884883005907
• NIH Device Record Key: dad1effb-49d8-4b67-a961-271e31ecea1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcroMetrix BB NAT WNV Negative Control
• Version Model Number: 960600
• 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	00884883005907 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-25

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