Panther Fusion®

Basic Information

• Brand Name: Panther Fusion®
• Primary DI: 15420045511477
• Version / Model: DNA BKV PROBE (ASR)
• Catalog Number: PRD-04992
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-08
• Public Version: 1
• Public Version Date: 2023-11-16
• Public Version Status: New
• Public Device Record Key: f1ed0596-b19b-4914-bb7b-d0a231cd4780

Device Description

BK virus (BKV) Probe ASR.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, specific, analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49852	BK virus (BKV) nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from BK virus (BKV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045511477	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -85 – -15 Degrees Celsius