CEDIA Antibiotic TDM Multi-Cal

GUDID 00884883007116

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00884883007116
• NIH Device Record Key: 8cc81234-2767-4a85-ba02-d15395845a72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Antibiotic TDM Multi-Cal
• Version Model Number: 08777934 190
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00884883007116 [Primary]

FDA Product Code

• DKB: Calibrators, Drug Mixture

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