Panther Fusion®

Basic Information

• Brand Name: Panther Fusion®
• Primary DI: 15420045515451
• Version / Model: KIT, OPEN ACCESS CARTRIDGES, 96-TEST, RNA/DNA ENZ
• Catalog Number: PRD-04303
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: d7b6cac0-77b6-4441-be49-28cb50342027

Device Description

Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests.

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: 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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60092	DNA amplification enzyme reagent IVD	A substance or reactant intended to be used as an enzyme in a molecular assay to facilitate the amplification of target deoxyribonucleic acid (DNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045515451	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius