FDA device listing
Real Time Nucleic Acid Amplification System
FDA device listing 1193378358 · Zhejiang Orient Gene Biotech Co., Ltd
Key facts
| Owner/operator | Zhejiang Orient Gene Biotech Co., Ltd |
|---|---|
| Owner/operator number | 10033347 |
| Product codes | OOI |
| Device names | OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | ZHEJIANG ORIENT GENE BIOTECH |
| Establishment registrations | 3008517993 |
| FEI numbers | 3008517993 |
| Establishment operations | Contract 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