PreciControl Syphilis 06923364162

GUDID 07613336183175

Syphilis PC Elecsys

Roche Diagnostics GmbH

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

• Primary Device ID: 07613336183175
• NIH Device Record Key: 4c3757db-7879-4393-ab66-5de1674e88af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl Syphilis
• Version Model Number: 06923364162
• Catalog Number: 06923364162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	07613336183175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK230839

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: 2023-11-08
• Device Publish Date: 2023-10-31

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• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05
• 04015630899579 - Elecsys Tuptake Assay: 2024-02-05