FDA device listing
Cleaning Solution,HT-Coag Calcium Chloride Reagent Kit,HT-Coag Imidazole Buffered Saline Reagent Kit,HTI Cleaning…
FDA device listing 1478742853 · High Technology, Inc.
Key facts
| Proprietary names | Cleaning Solution,HT-Coag Calcium Chloride Reagent Kit,HT-Coag Imidazole Buffered Saline Reagent Kit,HTI Cleaning Solution,HTI Enzymatic Cleaner,HTI Enzymatic Cleaner Concentrate,HTI Enzymatic Cleaner Drypack,Reagent Pack (Calibrant A, Calibrant B),Refill Solution for ISE Electrodes,Refill Solution for Reference Electrode,Shutdown Pack,Urine Dilute Solution,Washing Solution,Washing Solution… |
|---|---|
| Owner/operator | High Technology, Inc. |
| Owner/operator number | 10035029 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | High Technology, Inc. |
| Establishment registrations | 3013660430 |
| FEI numbers | 3013660430 |
| Establishment operations | Manufacturer, 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