HistoCore Peloris
The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated…
The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.
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 | Leica Biosystems Melbourne PTY Ltd, Australia |
|---|---|
| FDA product code | IEO |
| Device type | Processor, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3875 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-20 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HistoCore PELORIS 3 (100-120V) | In distribution | |
| HistoCore I-Scan Kit | In distribution | |
| HistoCore PELORIS 3 Barcode Scanner Kit | In distribution | |
| High Capacity Basket (with dividers) | In distribution | |
| Spaced Basket Kit | In distribution | |
| Basket Spaced | In distribution | |
| High Capacity Basket Kit | In distribution | |
| HistoCore PELORIS 3 Win10 Upgrade Kit | In distribution | |
| HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 25 |
| Thermo Fisher | Shandon Diagnostics Limited | 11 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 3 |
| Tissue-Tek VIP® 6 | Sakura Finetek U.S.A., Inc. | 2 |
| PathTezt® | Biocytech Corporation SDN BHD | 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
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 |
|---|---|---|---|---|---|---|
| Leica Biosystems Melbourne PTY Ltd | UDI-DI | 2025-04-02 | Class II | Release of Material/Component prior to receiving test results | There is a leakage issue associated with the tubing in the manifold of the instrument. | 77 units |
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.