NeuMoDx™ Lysis Buffer 5

Basic Information

• Brand Name: NeuMoDx™ Lysis Buffer 5
• Primary DI: 10814278020861
• Version / Model: 400900
• Catalog Number: 400900
• Company Name: Neumodx Molecular, Inc.
• Labeler DUNS: 078667309
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-12-13
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: 775c69b7-d3a5-4398-8a44-6cabf3caba65

Device Description

NeuMoDx™ Lysis Buffer 5

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00814278020864	GS1
Primary	10814278020861	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 23 Degrees Celsius