NeuMoDx™ Viral Lysis Buffer 401600
GUDID 00814278021250
NeuMoDx™ Viral Lysis Buffer
Neumodx Molecular, Inc.
Nucleic acid sequencing reagent kit IVD| Primary Device ID | 00814278021250 |
| NIH Device Record Key | 1a275d13-70e1-4812-8ad7-56cb5d69ef4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuMoDx™ Viral Lysis Buffer |
| Version Model Number | 4001600 |
| Catalog Number | 401600 |
| Company DUNS | 078667309 |
| Company Name | Neumodx Molecular, Inc. |
| Device Count | 2 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 Dimensions
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814278021250 [Unit of Use] |
| GS1 | 10814278021257 [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 | 2020-03-30 |
| Device Publish Date | 2020-03-20 |
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 | 2020-03-30NeuMoDx™ Viral Lysis Buffer |
| 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 |
Trademark Results [NeuMoDx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUMODX 87175050 not registered Live/Pending |
NeuMoDx Molecular, Inc. 2016-09-19 |
 NEUMODX 85865420 not registered Dead/Abandoned |
NEUMODX MOLECULAR, INC. 2013-03-04 |
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