MAS Omni Infectious BSI Positive Control Panel

GUDID 00884883007505

Microgenics Corporation

Multiple sexually transmitted pathogen nucleic acid IVD, control

• Primary Device ID: 00884883007505
• NIH Device Record Key: 10a80523-4bf3-42fd-914a-acfc4cdbc8a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Omni Infectious BSI Positive Control Panel
• Version Model Number: 10027480
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883007505 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2020-07-08
• Device Publish Date: 2020-06-30

Devices Manufactured by Microgenics Corporation

• 00884883009301 - MAS Omni•IMMUNE Max, Level 1: 2025-08-20
• 00884883009318 - MAS Omni•IMMUNE Max, Level 2: 2025-08-20
• 00884883009325 - MAS Omni•IMMUNE Max, Level 3: 2025-08-20
• 00884883009332 - MAS Omni•IMMUNE Max, Sample Pack: 2025-08-20
• 00884883009349 - MAS Omni•IMMUNE PRO Max, Level 1: 2025-08-20
• 00884883009356 - MAS Omni•IMMUNE PRO Max, Level 2: 2025-08-20
• 00884883009363 - MAS Omni•IMMUNE PRO Max, Level 3: 2025-08-20
• 00884883009370 - MAS Omni•IMMUNE PRO Max, Sample Pack: 2025-08-20