cobas¿ 4800 CTNG Test v20 07102569190

GUDID 00875197005356

Roche Molecular Systems, Inc.

Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005356
• NIH Device Record Key: 40c7c458-b80a-4637-a8e6-6ed7a811a9b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ 4800 CTNG Test v20
• Version Model Number: 2.0
• Catalog Number: 07102569190
• 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	00875197005356 [Primary]

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

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¿ 4800 CTNG Test v20]

• 00875197005363: 2.0
• 00875197005356: 2.0