FDA device listing
BD Simulset Software,BD Simultest CD3/HLA-DR,BD Simultest CD4/CD8,BD Simultest IMK Plus
FDA device listing 1625036503 · Becton Dickinson and Company
Key facts
| Proprietary names | BD Simulset Software,BD Simultest CD3/HLA-DR,BD Simultest CD4/CD8,BD Simultest IMK Plus |
|---|---|
| Owner/operator | Becton Dickinson and Company |
| Owner/operator number | 9922032 |
| Premarket submissions | K900078 |
| Product codes | GKZ |
| Device names | GKZ - Counter, Differential Cell |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5220 |
| Review panels | Hematology |
| Registered establishments | Becton, Dickinson and Company, BD Biosciences, Becton Dickinson Caribe, LTD |
| Establishment registrations | 3008352382, 3027394506 |
| FEI numbers | 3008352382, 3027394506 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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