NeuMoDxTM LDT Master Mix, DNA

Basic Information

• Brand Name: NeuMoDxTM LDT Master Mix, DNA
• Primary DI: 10814278020199
• Version / Model: 210100
• Catalog Number: 210100
• Company Name: Neumodx Molecular, Inc.
• Labeler DUNS: 078667309
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: 97961cfe-18cc-4444-ab60-8b65bf1755d0

Device Description

NeuMoDx LDT Master Mix, DNA

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: Yes
• 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
62623	Nucleic acid amplification mastermix reagent IVD	A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10814278020199	GS1
Unit of Use	00814278020192	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius