FDA device listing
Atellica DCA HbA1c Dx Reagent Kit
FDA device listing 1761396118 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Atellica DCA HbA1c Dx Reagent Kit |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Product codes | PDJ |
| Device names | PDJ - Hemoglobin A1c Test System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1373 |
| Review panels | Clinical Chemistry |
| Registered establishments | Siemens Healthcare Diagnostics, Inc. |
| Establishment registrations | 3009448641 |
| FEI numbers | 3009448641 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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