MGC Clinical DAU Control Set

GUDID 00884883001626

Microgenics Corporation

Multiple drugs of abuse IVD, control

• Primary Device ID: 00884883001626
• NIH Device Record Key: 0e2ab717-e527-47d8-9796-76320f15e677
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Clinical DAU Control Set
• Version Model Number: 100201
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883001626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040758

FDA Product Code

• DIF: Drug Mixture Control Materials

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-24
• Device Publish Date: 2017-09-28

Devices Manufactured by Microgenics Corporation

• 00884883008830 - MAS Diabetes Max-SP (Sample-Pack): 2024-05-29
• 00884883008823 - MAS Diabetes Max, Multi-pack: 2024-05-28
• 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