MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample Pack

GUDID 00884883009240

Microgenics Corporation

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00884883009240
• NIH Device Record Key: 57284667-0c27-44a1-a28a-b4e54f27073a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample Pack
• Version Model Number: OCRL-SP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883009240 [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: 2025-02-10
• Device Publish Date: 2025-01-31

Devices Manufactured by Microgenics Corporation

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• 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