FDA device listing
Red Blood Cell Lysis Buffer
FDA device listing 1293025549 · Zhejiang GENE SCIENCE Co., Ltd
Key facts
| Proprietary names | Red Blood Cell Lysis Buffer |
|---|---|
| Owner/operator | Zhejiang GENE SCIENCE Co., Ltd |
| Owner/operator number | 10071254 |
| Product codes | GGK |
| Device names | GGK - Products, Red-Cell Lysing Products |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8540 |
| Review panels | Hematology |
| 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