FDA device listing
BEB dengue igm and igg antibodies test
FDA device listing 1604091012 · Boston Easy Biotech Inc
Key facts
| Proprietary names | BEB dengue igm and igg antibodies test |
|---|---|
| Owner/operator | Boston Easy Biotech Inc |
| Owner/operator number | 10086310 |
| Product codes | NWY |
| Device names | NWY - Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.NWY |
| Review panels | Microbiology |
| Registered establishments | BOSTON EASY BIOTECH INC |
| Establishment registrations | 3024753119 |
| FEI numbers | 3024753119 |
| 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