FDA device listing
Adenovirus (2/6 & 20/11) Mouse Monoclonal Antibody,Anti-Chromogranin A, Clone Lk2H10,Anti-Cytokeratin Ae1/Ae3…
FDA device listing 1257131615 · MilliporeSigma
Key facts
| Proprietary names | Adenovirus (2/6 & 20/11) Mouse Monoclonal Antibody,Anti-Chromogranin A, Clone Lk2H10,Anti-Cytokeratin Ae1/Ae3, Recognizes Acidic & Basic Cytokeratins, Clone Ae1/Ae3,Anti-Cytomegalovirus, clone 8B1.2,ARID1A (EP303) Rabbit Monoclonal Primary Antibody,CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody,CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody,CMV (DDG9/CCH2) Mouse Monoclonal… |
|---|---|
| Owner/operator | MilliporeSigma |
| Owner/operator number | 1216103 |
| Product codes | MVU |
| Device names | MVU - Reagents, Specific, Analyte |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4020 |
| Review panels | Pathology |
| Registered establishments | CELL MARQUE CORP. |
| Establishment registrations | 1649339, 3017212430 |
| FEI numbers | 3000718726, 3017212430 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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