Access Syphilis Calibrators C80412

GUDID 15099590763633

The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. By comparing the light intensity generated by a sample to the cut-off value, the presence or absence of Treponema pallidum antibodies in the sample is determined.

Beckman Coulter, Inc.

Treponema pallidum total antibody IVD, calibrator

• Primary Device ID: 15099590763633
• NIH Device Record Key: 402ed24d-4f5f-4e2e-8f2c-22792daa26e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Syphilis Calibrators
• Version Model Number: C80412
• Catalog Number: C80412
• 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	15099590763633 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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.

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• 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: 2025-05-15The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. By comparing the light intensity generated by a sample to the cut-off value, the presence or absence of Treponema pallidum antibodies in the sample is determined.
• 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: 2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for