FDA device listing
IMMULITE 2000 American Cockroach I206,IMMULITE 2000 Baccharis W67,IMMULITE 2000 Bayberry Sweet Gale T218,IMMULITE 2000…
FDA device listing 1821299250 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | IMMULITE 2000 American Cockroach I206,IMMULITE 2000 Baccharis W67,IMMULITE 2000 Bayberry Sweet Gale T218,IMMULITE 2000 Dog Fennel W46,IMMULITE 2000 Hormodendrum Hordei M45,IMMULITE 2000 Live Oak T103,IMMULITE 2000 Locust tree T280,IMMULITE 2000 Privet T210,IMMULITE 2000 Red Mulberry T71,IMMULITE 2000 Stemphylium Solani M88,IMMULITE 2000 White Bald Cypress T37 |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K083853 |
| Product codes | DHB |
| Device names | DHB - System, Test, Radioallergosorbent (Rast) Immunological |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5750 |
| Review panels | Immunology |
| Registered establishments | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Establishment registrations | 3002806944 |
| FEI numbers | 3002806944 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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