Elecsys Syphilis 09015051162

GUDID 07613336228463

Roche Diagnostics GmbH

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