FDA device listing
Automated Liquid-Based Cytology Slide Preparation Machine GSTCT-50,Automatic Frozen Section Staining and Coverslipping…
FDA device listing 1828310751 · Zhejiang GENE SCIENCE Co., Ltd
Key facts
| Proprietary names | Automated Liquid-Based Cytology Slide Preparation Machine GSTCT-50,Automatic Frozen Section Staining and Coverslipping Machine (GSM210-1/GSM210-2),Full-Auto IHC Stainer (P17),Full-Auto IHC Stainer (P17 plus),Full-Auto Slide Stainer & Coverslipper,Full-Auto Slide Stainer & Coverslipper (GSM230),Full-Auto Slide Stainer & Coverslipper (GSM 240),Fully Automated Special Staining System,Liquid-based… |
|---|---|
| Owner/operator | Zhejiang GENE SCIENCE Co., Ltd |
| Owner/operator number | 10071254 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | ZHEJIANG GENE SCIENCE CO., LTD |
| Establishment registrations | 3016764932 |
| FEI numbers | 3016764932 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database