NeuMoDx™ Lysis Buffer 5 400900

GUDID 00814278020864

NeuMoDx™ Lysis Buffer 5

Neumodx Molecular, Inc.

Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD Molecular grade lysis reagent IVD

• Primary Device ID: 00814278020864
• NIH Device Record Key: 775c69b7-d3a5-4398-8a44-6cabf3caba65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuMoDx™ Lysis Buffer 5
• Version Model Number: 400900
• Catalog Number: 400900
• Company DUNS: 078667309
• Company Name: Neumodx Molecular, Inc.
• Device Count: 4
• 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

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814278020864 [Unit of Use]
GS1	10814278020861 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2021-12-22
• Device Publish Date: 2021-12-13

Devices Manufactured by Neumodx Molecular, Inc.

• 00814278020864 - NeuMoDx™ Lysis Buffer 5: 2021-12-22NeuMoDx™ Lysis Buffer 5
• 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: 2019-04-11 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