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.

• 15099590763626 - Access Syphilis Reagent: 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo
• 15099590763633 - Access Syphilis Calibrators: 2025-05-15 The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. B
• 15099590763640 - Access Syphilis QC: 2025-05-15The 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.
• 15099590763640 - Access Syphilis QC: 2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for
• 05099590798218 - DxH: 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
• 14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590209636 - DxH: 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and