Access Syphilis QC C80413

GUDID 15099590763640

The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for use on Access Immunoassay Systems.

Beckman Coulter, Inc.

Treponema pallidum total antibody IVD, control

• Primary Device ID: 15099590763640
• NIH Device Record Key: 9dd0c407-9953-4700-868d-7c9f3f201476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Syphilis QC
• Version Model Number: C80413
• Catalog Number: C80413
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15099590763640 [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: 2025-05-15
• Device Publish Date: 2025-05-07

Devices Manufactured by Beckman Coulter, Inc.

• 15099590799717 - MicroScan: 2025-12-25 MicroScan LabPro V5.03 System (US), Electronic
• 15099590799724 - MicroScan: 2025-12-25 MicroScan LabPro Connect V5.03 System (US), Electronic
• 15099590799755 - MicroScan: 2025-12-25 MicroScan LabPro V5.03 System DVD Kit (US)
• 15099590799762 - MicroScan: 2025-12-25 MicroScan LabPro Connect V5.03 System DVD Kit (US)
• 05099590798973 - MicroScan: 2025-12-16 MicroScan Neg MIC 65
• 05099590798980 - MicroScan: 2025-12-16 MicroScan Neg Combo 104
• 05099590798997 - MicroScan: 2025-12-16 MicroScan Neg Combo 105
• 05099590799000 - MicroScan: 2025-12-16 MicroScan Neg Combo 106