Panther Fusion®

Basic Information

• Brand Name: Panther Fusion®
• Primary DI: 15420045510463
• Version / Model: EXTRACTION REAGENT-X, 960T, IVD
• Catalog Number: PRD-04477
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-30
• Public Version: 2
• Public Version Date: 2023-11-30
• Public Version Status: Update
• Public Device Record Key: bae9edb7-20cc-439d-ac21-3c9795c79d98

Device Description

Panther Fusion® Extraction Reagent-X.

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: 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
NJR	Nucleic acid amplification assay system, group b streptococcus, direct specimen test	Microbiology	866.3740	1
JJH	Clinical sample concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61194	Nucleic acid technique (NAT) kit IVD	A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045510463	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius