FDA device listing
BD HLA-B27 Application Module,BD HLA-B27 Kit,BD HLA-B27 Software
FDA device listing 1163657443 · Becton Dickinson and Company
Key facts
| Proprietary names | BD HLA-B27 Application Module,BD HLA-B27 Kit,BD HLA-B27 Software |
|---|---|
| Owner/operator | Becton Dickinson and Company |
| Owner/operator number | 9922032 |
| Premarket submissions | BK050073 |
| Product codes | MZI |
| Device names | MZI - Test, Qualitative, For Hla, Non-Diagnostic |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.MZI |
| 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