GENTC

GUDID 00884883007123

Microgenics Corporation

Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883007123
• NIH Device Record Key: 1276897b-cae9-4e60-9cae-8fe08c0d3994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTC
• Version Model Number: 08772525 190
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883007123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913470

FDA Product Code

• LCD: Enzyme Immunoassay, Gentamicin

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: 2019-11-28
• Device Publish Date: 2019-11-20

Devices Manufactured by Microgenics Corporation

• 00884883006027 - Acrometrix BB NAT HBV Positive Control: 2022-10-17
• 00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays: 2021-11-11
• 07613336190791 - OXY DRI Oxycodone: 2021-11-03
• 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