navify® Lab Operations 10382716001

GUDID 07613336234402

Roche Diagnostics GmbH

Clinical laboratory information system application software

• Primary Device ID: 07613336234402
• NIH Device Record Key: 666d0170-aa8c-4199-a75e-d0d9d65e403b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: navify® Lab Operations
• Version Model Number: 10382716001
• Catalog Number: 10382716001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336234402 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

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: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by Roche Diagnostics GmbH

• 07613336234402 - navify® Lab Operations: 2024-11-05
• 07613336234402 - navify® Lab Operations: 2024-11-05
• 07613336217665 - Elecsys Total PSA: 2024-11-01
• 07613336217672 - Elecsys free PSA: 2024-11-01
• 07613336218440 - Elecsys Rubella IgM: 2024-11-01
• 07613336217146 - Elecsys AFP: 2024-10-30
• 07613336218426 - Elecsys Prolactin II: 2024-10-16
• 07613336160367 - Elecsys Anti-HBs II: 2024-10-10
• 07613336230367 - Elecsys Anti-HBs II: 2024-08-28