FDA device listing
APC anti-human CD10,APC anti-human CD103,APC anti-human CD117 (c-kit),APC anti-human CD11b,APC anti-human CD11c,APC…
FDA device listing 1649984461 · Biolegend, Inc.
Key facts
| Proprietary names | APC anti-human CD10,APC anti-human CD103,APC anti-human CD117 (c-kit),APC anti-human CD11b,APC anti-human CD11c,APC anti-human CD123,APC anti-human CD127,APC anti-human CD13,APC anti-human CD138,APC anti-human CD14,APC anti-human CD16,APC anti-human CD185,APC anti-human CD19,APC anti-human CD1a,APC anti-human CD2,APC anti-human CD20,APC anti-human CD200,APC anti-human CD223,APC anti-human CD23,APC… |
|---|---|
| Owner/operator | Biolegend, Inc. |
| Owner/operator number | 9095640 |
| Product codes | MVU |
| Device names | MVU - Reagents, Specific, Analyte |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4020 |
| Review panels | Pathology |
| Registered establishments | BIOLEGEND, INC. |
| Establishment registrations | 3015258926 |
| FEI numbers | 3015258926 |
| Establishment operations | Manufacturer |
| 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