cobas PCR Media Dual Swab Sample Kit 07958021190

GUDID 00875197005738

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)

• Primary Device ID: 00875197005738
• NIH Device Record Key: dad26b9d-9a88-40c2-9a93-3fd4695ff15b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas PCR Media Dual Swab Sample Kit
• Version Model Number: 07958021190
• Catalog Number: 07958021190
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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	00875197005738 [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: 2017-06-27

Devices Manufactured by Roche Molecular Systems, Inc.

• 04015630936540 - cobas p630 Pre-Analytical Pipettor: 2022-09-16
• 04015630936557 - DOCKING STATION SHORT: 2022-09-16
• 00875197006445 - cobas® NHP Negative Control Kit: 2022-08-09
• 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