Elecsys Anti-CMV 09118551162

GUDID 07613336228449

Roche Diagnostics GmbH

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228449
• NIH Device Record Key: 1dfb042e-403b-40c2-b82c-ff071682b465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-CMV
• Version Model Number: 09118551162
• Catalog Number: 09118551162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 9
• 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	07613336183069 [Primary]
GS1	07613336228449 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK230840

FDA Product Code

• MZE: Test, donor, CMV

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: 2023-12-13
• Device Publish Date: 2023-12-05

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