ASP Device; ASP System; Rose Prep Pro
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in…
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens.
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 | ASP Health Inc., United States |
|---|---|
| FDA product code | KPA |
| Device type | Slide Stainer, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-05 |
| Record revised | 2025-02-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 80 % RH; Storage environment humidity 20 to 80 % RH; Handling environment temperature 18 to 30 °C; Storage environment temperature 18 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REV P | 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 |
| Bond-Prime automated stainer | Leica Biosystems Melbourne PTY Ltd | 2 |
| Decloaking Chamber™ NxGen Reconditioned | Biocare Medical, LLC | 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.