NeuMoDx™ Vantage Viral Lysis Buffer 401500
GUDID 00814278021304
NeuMoDx™ Vantage Viral Lysis Buffer
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 | 00814278021304 |
| NIH Device Record Key | 5db87a1f-3f80-4e87-bd2f-f22f12b75eb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuMoDx™ Vantage Viral Lysis Buffer |
| Version Model Number | 401500 |
| Catalog Number | 401500 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814278021304 [Unit of Use] |
| GS1 | 10814278021301 [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 | 2021-12-22 NeuMoDx™ Lysis Buffer 5 |
| 00814278021304 - NeuMoDx™ Vantage Viral Lysis Buffer | 2021-12-22NeuMoDx™ Vantage Viral Lysis Buffer |
| 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 |
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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