MAS Diabetes Max, Multi-pack

GUDID 00884883008823

Microgenics Corporation

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 00884883008823
• NIH Device Record Key: ecf9664b-3608-45f9-bd14-218efcb2cfdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Diabetes Max, Multi-pack
• Version Model Number: B40000687
• 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	00884883008823 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And 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: 2024-05-28
• Device Publish Date: 2024-05-20

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