BD MAX™ Vaginal Panel
Catalogue number 443712, listed by Becton, Dickinson AND Company, United States, under Instrumentation For Clinical Multiplex Test Systems. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Xiamen Zeesan Biotech Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
| Jiangsu Bioperfectus Technologies Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 3 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | NSU |
| Device type | Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201017 |
| Record published | 2017-03-23 |
| Record revised | 2025-05-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 443712 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spartan RX CYP2C19 System | Spartan Bioscience, Inc. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| Aptima® | Hologic, Inc. | 7 |
| OpsisDx | Entopsis, Inc. | 5 |
| Affymetrix | Affymetrix, Inc. | 4 |
| FilmArray® 2.0 Instrument Ngds Configuration | BioFire Defense, LLC | 3 |
| FilmArray® 2.0 Instrument | BioFire Diagnostics, LLC | 3 |
| Opus | Bio-Rad Laboratories Inc. | 3 |
| FilmArray® Torch System Base | BioFire Diagnostics, LLC | 3 |
| FilmArray® Torch Module | BioFire Diagnostics, LLC | 3 |
| Biofire ® Spotfire ® Module | BioFire Diagnostics, LLC | 2 |
| Biofire ® Spotfire ® Control Station | BioFire Diagnostics, LLC | 2 |
Showing 12 of 110. All products under Instrumentation For Clinical Multiplex Test Systems
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2019-07-17 | Class II | Process control | The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. | 666 units | 2020-05-13 |
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.