FDA device listing
Estradiol EIA,Estradiol ELISA,Estradiol Ultrasensitive EIA,Ultrasensitive Estradiol ELISA
FDA device listing 1811591938 · AMERICAN LABORATORY PRODUCTS CO., LTD.
Key facts
| Proprietary names | Estradiol EIA,Estradiol ELISA,Estradiol Ultrasensitive EIA,Ultrasensitive Estradiol ELISA |
|---|---|
| Owner/operator | AMERICAN LABORATORY PRODUCTS CO., LTD. |
| Owner/operator number | 9000664 |
| Product codes | CHP |
| Device names | CHP - Radioimmunoassay, Estradiol |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1260 |
| Review panels | Clinical Chemistry |
| Registered establishments | American Laboratory Products Company |
| Establishment registrations | 1222302 |
| FEI numbers | 1000121039 |
| 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