BD Totalys™ SlidePrep Non-GYN Test Kit
BD Totalys SlidePrep Non-GYN Test Kit
26manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (8), Shanghai (4). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
Showing 12 of 26. All 26 manufacturers in China registered for Slides, Microscope
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | KEW |
| Device type | Slides, Microscope |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-08 |
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 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 491304 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | NEW Erie Scientific LLC | 491 |
| Marienfeld Superior | Paul Marienfeld Gmbh & Co. KG. | 379 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 137 |
| Globe Scientific | Globe Scientific, LLC | 93 |
| Cancer | Yancheng Jingwei Chemicals Co., Ltd. | 88 |
| Microscope Slides | Typenex Medical, LLC | 86 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 84 |
| Hareta | Yancheng Jingwei Chemicals Co., Ltd. | 78 |
| Rankin | Yancheng Jingwei Chemicals Co., Ltd. | 73 |
| Pathsupply | Yancheng Jingwei Chemicals Co., Ltd. | 60 |
| KT ™ Premium Slides | Slmp, LLC | 54 |
| Tanner | Yancheng Jingwei Chemicals Co., Ltd. | 29 |
Showing 12 of 49. All products under Slides, Microscope
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.