MAS anti-HBs Positive Control

GUDID 00884883007529

Microgenics Corporation

Hepatitis B virus antigen/antibody marker IVD, control

• Primary Device ID: 00884883007529
• NIH Device Record Key: 46a8362a-1913-432f-aeb8-973688abbcb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS anti-HBs Positive Control
• Version Model Number: 10027482
• 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	00884883007529 [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

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• 00884883007772 - MAS SARS-CoV-2 Negative Control: 2021-03-15