NeuMoDx™ Vantage Viral Lysis Buffer
Catalogue number 401500, listed by Neumodx Molecular, Inc., United States, under General Purpose Reagent. 30 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Takara Biotechnology (Dalian) Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent
Record
| Listed by | Neumodx Molecular, Inc., United States |
|---|---|
| FDA product code | PPM |
| Device type | General Purpose Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Premarket notification | Exempt |
| Record published | 2021-12-13 |
| Record revised | 2025-08-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 28 °C |
| Sizes | Total volume 1 l |
| Distribution end date | 2025-08-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 401500 | Total Volume 1 l | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 62 |
| Epredia | Richard-Allan Scientific LLC | 59 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 46 |
| Vysis | Abbott Molecular, Inc. | 34 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 33 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 25 |
| Immunalysis | Immunalysis Corporation | 22 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 22 |
| Bond | Leica Biosystems Newcastle Ltd | 16 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 16 |
| Synchron | Beckman Coulter, Inc. | 13 |
| Immy | Immuno-Mycologics, Inc. | 12 |
Showing 12 of 617. All products under General Purpose Reagent
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-05-24 | Class II | Employee error | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics perf | 20,016 cartridges |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.