MAS Syphilis Positive Control

GUDID 00884883007536

Microgenics Corporation

Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control

• Primary Device ID: 00884883007536
• NIH Device Record Key: 302891b2-334e-4518-adeb-c217cb6a7c72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Syphilis Positive Control
• Version Model Number: 10027483
• 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	00884883007536 [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

• 00884883006027 - Acrometrix BB NAT HBV Positive Control: 2022-10-17
• 00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays: 2021-11-11
• 07613336190791 - OXY DRI Oxycodone: 2021-11-03
• 00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays: 2021-05-13
• 00884883007765 - MAS SARS-CoV-2 IgG Positive Control: 2021-03-15
• 00884883007772 - MAS SARS-CoV-2 Negative Control: 2021-03-15
• 07613336154045 - OXY Oxycodone: 2020-09-17
• 00884883007505 - MAS Omni Infectious BSI Positive Control Panel: 2020-07-08