cobas¿ MRSASA Test¿ 06768113190

GUDID 00875197004410

Roche Molecular Systems, Inc.

MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197004410
• NIH Device Record Key: f6fe8a79-b555-4e3d-88d1-ee40f38f2050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ MRSASA Test¿
• Version Model Number: 1.0
• Catalog Number: 06768113190
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197004410 [Primary]

FDA Product Code

• OOI: real time Nucleic acid amplification system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-31

On-Brand Devices [cobas¿ MRSASA Test¿]

• 00875197004427: 1.0
• 00875197004410: 1.0