NeuMoDx SARS-CoV-2 Test Strip 300800

GUDID 00814278021267

Neumodx Molecular, Inc.

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00814278021267
• NIH Device Record Key: 42ed7a9d-2937-4d32-b083-e0e4c5bd4b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuMoDx SARS-CoV-2 Test Strip
• Version Model Number: 300800
• Catalog Number: 300800
• Company DUNS: 078667309
• Company Name: Neumodx Molecular, Inc.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814278021267 [Unit of Use]
GS1	10814278021264 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

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: 2020-05-01
• Device Publish Date: 2020-04-23

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
• 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: 2019-04-11 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