AccessGUDID - DEVICE: Panther Fusion® (15420045510463)

GUDID

Device Identifier (DI) Information

Brand Name: Panther Fusion®
Version or Model: EXTRACTION REAGENT-X, 960T, IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-04477
Company Name: Hologic, Inc.

Primary DI Number: 15420045510463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Panther Fusion® Extraction Reagent-X.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJR	Nucleic acid amplification assay system, group b streptococcus, direct specimen test
JJH	Clinical sample concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bae9edb7-20cc-439d-ac21-3c9795c79d98
Public Version Date: November 30, 2023
Public Version Number: 2
DI Record Publish Date: July 30, 2019