AccessGUDID - DEVICE: NeuMoDx™ Vantage Viral Lysis Buffer (10814278021301)

GUDID

Device Identifier (DI) Information

Brand Name: NeuMoDx™ Vantage Viral Lysis Buffer
Version or Model: 401500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 401500
Company Name: Neumodx Molecular, Inc.

Primary DI Number: 10814278021301
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2025
Device Count: 2
Labeler D-U-N-S® Number*: 078667309 *Terms of Use

Device Description: NeuMoDx™ Vantage Viral Lysis Buffer

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?
62692	Molecular grade lysis reagent IVD	A substance or reactant containing a protein denaturant (e.g., guanidine thiocyanate) intended to be used alone or in combination with other IVDs for the extraction of nucleic acids (e.g., DNA, RNA) from cells in a clinical specimen in preparation for further analysis using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 15 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Liter

Device Record Status

Public Device Record Key: 5db87a1f-3f80-4e87-bd2f-f22f12b75eb6
Public Version Date: August 08, 2025
Public Version Number: 3
DI Record Publish Date: December 13, 2021