QMS Vancomycin Immunoassay

GUDID 00884883012837

Microgenics Corporation

Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00884883012837
• NIH Device Record Key: bf872922-c8b1-46fb-b6d5-f07f51f90030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMS Vancomycin Immunoassay
• Version Model Number: 10017224
• 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	00884883012837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050419

FDA Product Code

• LEH: Radioimmunoassay, Vancomycin

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: 2016-09-22

On-Brand Devices [QMS Vancomycin Immunoassay]

• 00884883012837: 10017224
• 00884883011243: 0373597
• 00884883011182: 0373589