cobas e 801 Immunoassay Analyzer 07682913001

GUDID 04015630946198

Roche Diagnostics GmbH

Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 04015630946198
• NIH Device Record Key: e006eec2-6188-4dad-8fff-807a234052b0
• Commercial Distribution Discontinuation: 2019-12-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: cobas e 801 Immunoassay Analyzer
• Version Model Number: 07682913001
• Catalog Number: 07682913001
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	04015630946198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162606

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-03-23

On-Brand Devices [cobas e 801 Immunoassay Analyzer]

• 07613336158562: 08459606001
• 07613336158456: 08454345001
• 04015630946198: 07682913001