cobas® prime Pre-analytical System 08988242001

GUDID 07613336171325

Roche Molecular Systems, Inc.

Specimen processing instrument IVD, automated

• Primary Device ID: 07613336171325
• NIH Device Record Key: 93b96758-9e99-4173-9fc7-a4951f0be562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® prime Pre-analytical System
• Version Model Number: 08988242001
• Catalog Number: 08988242001
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336171325 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, 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: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [cobas® prime Pre-analytical System]

• 07613336171332: 08988277001
• 07613336171325: 08988242001