cobas® vivoDx MRSA Control Media 08064768190

GUDID 00875197005820

Roche Molecular Systems, Inc.

MRSA phenotype detection IVD, kit, bioassay

• Primary Device ID: 00875197005820
• NIH Device Record Key: 49ac5ffb-e2f7-4b50-94dd-55e6081af52d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® vivoDx MRSA Control Media
• Version Model Number: 08064768190
• Catalog Number: 08064768190
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197005820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190016

FDA Product Code

• QIV: Culture-based short-term incubation antimicrobial resistance assay

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: 2020-01-23
• Device Publish Date: 2020-01-15

Devices Manufactured by Roche Molecular Systems, Inc.

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• 04015630929009 - cobas x 480 Analyzer: 2022-06-10
• 00875197006391 - cobas® HCV: 2021-12-22
• 00875197006407 - cobas® HIV-1: 2021-12-22
• 00875197006414 - cobas® HBV: 2021-12-22
• 00875197006421 - cobas® CMV: 2021-12-22