AccessGUDID - DEVICE: NeuMoDx™ Viral Lysis Buffer (10814278021257)

GUDID

Device Identifier (DI) Information

Brand Name: NeuMoDx™ Viral Lysis Buffer
Version or Model: 401600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 401600
Company Name: Neumodx Molecular, Inc.

Primary DI Number: 10814278021257
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™ 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?
62173	Nucleic acid sequencing reagent kit IVD	A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.	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: 1a275d13-70e1-4812-8ad7-56cb5d69ef4b
Public Version Date: August 08, 2025
Public Version Number: 4
DI Record Publish Date: March 20, 2020