Bond-Prime Automated Stainer
The BOND system is designed for immunostaining histological specimens mounted on microscope slides.
14manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 14. All 14 manufacturers in China registered for Slide Stainer, Automated
Record
| Listed by | Leica Biosystems Melbourne PTY Ltd, Australia |
|---|---|
| FDA product code | KPA |
| Device type | Slide Stainer, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-18 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BOND-PRIME | In distribution | |
| BOND-PRIME | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 54 |
| Thermo Fisher | Shandon Diagnostics Limited | 27 |
| Bond | Leica Biosystems Melbourne PTY Ltd | 21 |
| HistoPro® | Rushabh Instruments, LLC | 5 |
| intelliPATH Plus | Biocare Medical, LLC | 4 |
| Alinity | Abbott Laboratories | 4 |
| intelliPATH MAX | Biocare Medical, LLC | 4 |
| Bond | Leica Biosystems Newcastle Ltd | 4 |
| Dako | Agilent Technologies, Inc | 3 |
| Advia Autoslide® Slide Maker Stainer | Siemens Healthcare Diagnostics Inc | 3 |
| Decloaking Chamber™ NxGen Reconditioned | Biocare Medical, LLC | 2 |
| QuickSlide™ | Hardy Diagnostics | 2 |
Showing 12 of 153. All products under Slide Stainer, Automated
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.