FDA device listing
Calibration Strips,UrineRS A10,UrineRS E10,UrineRS H10,UrineRS H11,UrineRS H13,UrineRS H14
FDA device listing 1024168954 · High Technology, Inc.
Key facts
| Proprietary names | Calibration Strips,UrineRS A10,UrineRS E10,UrineRS H10,UrineRS H11,UrineRS H13,UrineRS H14 |
|---|---|
| Owner/operator | High Technology, Inc. |
| Owner/operator number | 10035029 |
| Product codes | JIR |
| Device names | JIR - Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1645 |
| Review panels | Clinical Chemistry |
| Registered establishments | High Technology, Inc. |
| Establishment registrations | 3013660430 |
| FEI numbers | 3013660430 |
| Establishment operations | Repackager/Relabeler |
| 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