PathTezt®
PathTezt® Infinity fully automated cytology slide processor with Autoloader. Fully walk away systems which provides continuous loading of sample up to 120 samples per batch
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Biocytech Corporation SDN BHD, Malaysia |
|---|---|
| FDA product code | IEO |
| Device type | Processor, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3875 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PTIA-2021 | In distribution | |
| LBC-2009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 25 |
| Thermo Fisher | Shandon Diagnostics Limited | 11 |
| HistoCore Peloris | Leica Biosystems Melbourne PTY Ltd | 9 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 3 |
| Tissue-Tek VIP® 6 | Sakura Finetek U.S.A., Inc. | 2 |
| Tissue-Tek VIP® | Sakura Finetek U.S.A., Inc. | 2 |
| Basket | Leica Biosystems Nussloch Gmbh | 1 |
| Basket, assy., large | Leica Biosystems Nussloch Gmbh | 1 |
| Anybattery | Anybattery, Inc | 1 |
| Leica ASP300 S | Leica Biosystems Nussloch Gmbh | 1 |
| HistoPro® | Rushabh Instruments, LLC | 1 |
| ASP6025 China | Leica Biosystems Nussloch Gmbh | 1 |
Showing 12 of 52. All products under Processor, Tissue, 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.