NeuMoDxTM GBS Test Strip

Basic Information

• Brand Name: NeuMoDxTM GBS Test Strip
• Primary DI: 10814278020045
• Version / Model: 200400
• Catalog Number: 200400
• Company Name: Neumodx Molecular, Inc.
• Labeler DUNS: 078667309
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-04-03
• Public Version: 1
• Public Version Date: 2019-04-11
• Public Version Status: New
• Public Device Record Key: bb4a4def-6a0f-4d50-a012-e302e50bc060

Device Description

NeuMoDx GBS Test Strip

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
NJR	Nucleic acid amplification assay system, group b streptococcus, direct specimen test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51756	Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10814278020045	GS1
Unit of Use	00814278020048	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173725	000

Storage Conditions

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