DRI Benzodiazepine Assay

GUDID 00884883011649

Microgenics Corporation

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883011649
• NIH Device Record Key: 39721607-cc35-4b8a-8340-3f53b0b76e71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Benzodiazepine Assay
• Version Model Number: 10015644
• 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	00884883011649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173963

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazipine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-15
• Device Publish Date: 2016-09-22

On-Brand Devices [DRI Benzodiazepine Assay]

• 00884883011649: 10015644
• 00884883002845: 0040
• 00884883002548: 0039