FDA device listing
i-STAT 9V NiMH rechargeable battery,i-STAT Alinity Base Station,i-STAT Alinity Battery,i-STAT Alinity Printer Kit,i-STAT…
FDA device listing 1873382098 · HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
Key facts
| Proprietary names | i-STAT 9V NiMH rechargeable battery,i-STAT Alinity Base Station,i-STAT Alinity Battery,i-STAT Alinity Printer Kit,i-STAT Portable Printer,i-STAT Printer Kit |
|---|---|
| Owner/operator | HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. |
| Owner/operator number | 9058334 |
| Product codes | JQP |
| Device names | JQP - Calculator/Data Processing Module, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2100 |
| Review panels | Clinical Chemistry |
| Registered establishments | DONGGUAN BAO KANG DIAN ZI KE JI LIMITED |
| Establishment registrations | 3020978007 |
| FEI numbers | 3020978007 |
| 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