cobas e 801 Immunoassay analyzer 08454345001

GUDID 07613336158456

Roche Diagnostics GmbH

Chemiluminescent immunoassay analyser IVD, automated 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: 07613336158456
• NIH Device Record Key: 99804d25-ea2d-486a-ae79-b9b4d55621d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas e 801 Immunoassay analyzer
• Version Model Number: 08454345001
• Catalog Number: 08454345001
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336158456 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-03
• Device Publish Date: 2019-04-25

On-Brand Devices [cobas e 801 Immunoassay analyzer]

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