Elecsys Syphilis 09015051162

GUDID 07613336228463

Roche Diagnostics GmbH

Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228463
• NIH Device Record Key: 794f1ba2-00ee-4475-b949-55894e46b5c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Syphilis
• Version Model Number: 09015051162
• Catalog Number: 09015051162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 20
• 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	07613336183083 [Primary]
GS1	07613336228463 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK230839

FDA Product Code

• MYR: Test, donor, syphilis, antigens, treponemal

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: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [Elecsys Syphilis]

• 07613336171998: Syphilis Elecsys E2G 300 V2
• 07613336171950: Syphilis Elecsys cobas e 100 V2
• 07613336228463: 09015051162