QMS Everolimus Immunoassay

GUDID 00884883000537

Microgenics Corporation

Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00884883000537
• NIH Device Record Key: 51ea7439-0550-4119-9568-6a4ee81329e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMS Everolimus Immunoassay
• Version Model Number: 0380005
• 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	00884883000537 [Primary]

FDA Product Code

• OUF: Everolimus Immunoassay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [QMS Everolimus Immunoassay]

• 00884883011687: 0380000
• 00884883000537: 0380005