MAS OmniCORE Max, Level 2

GUDID 00884883009264

Microgenics Corporation

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00884883009264
• NIH Device Record Key: 0a3a1ac3-5ad0-4f5c-b78d-58a256b2443e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS OmniCORE Max, Level 2
• Version Model Number: OCRM-202
• 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	00884883009264 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2025-07-07
• Device Publish Date: 2025-06-27

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