FDA device listing
iFlash-hGH
FDA device listing 1694652518 · SHENZHEN YHLO BIOTECH CO., LTD.
Key facts
| Proprietary names | iFlash-hGH |
|---|---|
| Owner/operator | SHENZHEN YHLO BIOTECH CO., LTD. |
| Owner/operator number | 10082247 |
| Product codes | CFL |
| Device names | CFL - Radioimmunoassay, Human Growth Hormone |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1370 |
| Review panels | Clinical Chemistry |
| Registered establishments | SHENZHEN YHLO BIOTECH CO., LTD. |
| Establishment registrations | 3017019647 |
| FEI numbers | 3017019647 |
| 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