AccessGUDID - DEVICE: Panther Fusion® (15420045510470)

GUDID

Device Identifier (DI) Information

Brand Name: Panther Fusion®
Version or Model: INTERNAL CONTROL-X, 960T, IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-04476
Company Name: Hologic, Inc.

Primary DI Number: 15420045510470
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Panther Fusion® Internal Control-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?
60094	Exogenous DNA/RNA internal control IVD, kit	A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.	Active	false

FDA Product Code

[?]

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

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6eca6d64-7d7b-4900-9752-0f5f7242bf83
Public Version Date: July 22, 2024
Public Version Number: 2
DI Record Publish Date: July 30, 2019