Elecsys Syphilis 09015051190

GUDID 07613336171998

Syphilis Elecsys E2G 300 V2

Roche Diagnostics GmbH

Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336171998
• NIH Device Record Key: 45df632f-ae84-4038-9cb3-c8ed18bbbb73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Syphilis
• Version Model Number: 09015051190
• Catalog Number: 09015051190
• 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	07613336171998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211302

FDA Product Code

• LIP: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [Elecsys Syphilis]

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