QuickSlide™
GramPRO 3, Automated Gram Stain Instrument. Intended to be used to perform a Gram stain sequence on slides containing biological specimens in preparation for subsequent microscopic…
GramPRO 3, Automated Gram Stain Instrument. Intended to be used to perform a Gram stain sequence on slides containing biological specimens in preparation for subsequent microscopic analysis. For in vitro diagnostic use.
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 | Hardy Diagnostics, United States |
|---|---|
| FDA product code | KPA |
| Device type | Slide Stainer, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-25 |
| Record revised | 2024-08-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2024-08-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GP3 | In distribution | |
| HP1 | Withdrawn |
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-16 | Class II | Nonconforming Material/Component | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. | 69 units | 2022-07-28 |
| 2016-05-24 | Class II | Under Investigation by firm | Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. | 25 | 2017-03-03 |
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.