UroVysion 02J27-095

GUDID 00884999002180

UroVysion Bladder Cancer Kit

ABBOTT MOLECULAR INC.

Bladder tumour-associated mutation IVD, probe

• Primary Device ID: 00884999002180
• NIH Device Record Key: 5e51d3b0-4700-49b8-b69e-4ee77f1dcfdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroVysion
• Version Model Number: 02J27-095
• Catalog Number: 02J27-095
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR 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

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999002180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030052

FDA Product Code

• NSD: Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2014-11-20

On-Brand Devices [UroVysion]

• 00884999002180: UroVysion Bladder Cancer Kit
• 00884999002142: UroVysion Bladder Cancer Kit
• 00884999002128: ProbeChek UroVysion Bladder Cancer Kit Control Slides