Elecsys Toxo IgM 09755861190

GUDID 07613336218464

Roche Diagnostics GmbH

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336218464
• NIH Device Record Key: d2a436cb-b881-4d64-b698-e956fc4bf96b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Toxo IgM
• Version Model Number: 09755861190
• Catalog Number: 09755861190
• 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	07613336218464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162678

FDA Product Code

• LGD: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

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: 2024-08-21
• Device Publish Date: 2024-08-13

Devices Manufactured by Roche Diagnostics GmbH

• 07613336182994 - PreciControl Release HBsAg II: 2024-11-15
• 07613336228456 - Elecsys HBsAg II: 2024-11-15
• 07613336183137 - Elecsys HBsAg II Auto Confirm: 2024-11-15
• 07613336183168 - PreciControl HBsAg II: 2024-11-15
• 07613336183236 - PreciControl HBsAg II Auto Confirm: 2024-11-15
• 07613336234402 - navify® Lab Operations: 2024-11-05
• 07613336217665 - Elecsys Total PSA: 2024-11-01
• 07613336217672 - Elecsys free PSA: 2024-11-01