cobas HPV Positive Control 07460171190

GUDID 00875197005769

Roche Molecular Systems, Inc.

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005769
• NIH Device Record Key: 745f5d83-3e1a-4574-bf64-09045bb4fd2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas HPV Positive Control
• Version Model Number: 07460171190
• Catalog Number: 07460171190
• 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: true
• 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	00875197005769 [Primary]

FDA Product Code

• MAQ: Kit, Dna Detection, Human Papillomavirus

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: 2021-06-14
• Device Publish Date: 2021-06-04

Devices Manufactured by Roche Molecular Systems, Inc.

• 00875197006896 - cobas HPV Positive Control Kit: 2024-06-14
• 00875197006889 - cobas HPV: 2024-06-13
• 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