UroVysion

Basic Information

• Brand Name: UroVysion
• Primary DI: 00884999002128
• Version / Model: 02J27-011
• Catalog Number: 02J27-011
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-20
• Public Version: 3
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 4a36fd6c-30da-4dc2-95f5-08a4217c12bb

Device Description

ProbeChek UroVysion Bladder Cancer Kit Control Slides

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYU	Dna-probe kit, human chromosome	Immunology	866.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61102	Bladder tumour-associated mutation IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired mutations associated with bladder cancer e.g., aneuploidies of chromosome 3, 7 and 17, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999002128	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dessicated-protect from humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius