FDA device listing
MAGICL FT3 (CLIA),MAGICL T3 (CLIA),T3 Fast Test Kit (Immunofluorescence Assay)
FDA device listing 1817866706 · Getein Biotech, Inc.
Key facts
| Proprietary names | MAGICL FT3 (CLIA),MAGICL T3 (CLIA),T3 Fast Test Kit (Immunofluorescence Assay) |
|---|---|
| Owner/operator | Getein Biotech, Inc. |
| Owner/operator number | 10064252 |
| Product codes | CDP |
| Device names | CDP - Radioimmunoassay, Total Triiodothyronine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1710 |
| Review panels | Clinical Chemistry |
| Registered establishments | GETEIN BIOTECH, INC. |
| Establishment registrations | 3009984016 |
| FEI numbers | 3009984016 |
| 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