NeuMoDxTM GBS Test Strip 200400

GUDID 10814278020045

NeuMoDx GBS Test Strip

Neumodx Molecular, Inc.

Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent

• Primary Device ID: 10814278020045
• NIH Device Record Key: bb4a4def-6a0f-4d50-a012-e302e50bc060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuMoDxTM GBS Test Strip
• Version Model Number: 200400
• Catalog Number: 200400
• Company DUNS: 078667309
• Company Name: Neumodx Molecular, Inc.
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814278020048 [Unit of Use]
GS1	10814278020045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173725

FDA Product Code

• NJR: Nucleic acid amplification assay system, group b streptococcus, direct specimen test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-11
• Device Publish Date: 2019-04-03

Devices Manufactured by Neumodx Molecular, Inc.

• 00814278020864 - NeuMoDx™ Lysis Buffer 5: 2021-12-22 NeuMoDx™ Lysis Buffer 5
• 00814278021304 - NeuMoDx™ Vantage Viral Lysis Buffer: 2021-12-22 NeuMoDx™ Vantage Viral Lysis Buffer
• 00814278021267 - NeuMoDx SARS-CoV-2 Test Strip: 2020-05-01
• 00814278021250 - NeuMoDx™ Viral Lysis Buffer: 2020-03-30 NeuMoDx™ Viral Lysis Buffer
• 00814278021212 - NeuMoDx™ Lysis Buffer 6: 2020-03-27 NeuMoDx™ Lysis Buffer 6
• 10814278020045 - NeuMoDxTM GBS Test Strip: 2019-04-11NeuMoDx GBS Test Strip
• 10814278020045 - NeuMoDxTM GBS Test Strip: 2019-04-11 NeuMoDx GBS Test Strip
• 00814278020000 - NeuMoDxTM 96 Molecular System: 2019-04-08 NeuMoDx 96 Molecular System
• 10814278020199 - NeuMoDxTM LDT Master Mix, DNA: 2019-04-08 NeuMoDx LDT Master Mix, DNA