FDA device listing
MALACHITE GREEN OXLT,MALACHITE GREEN SOLUTION
FDA device listing 1611232152 · MilliporeSigma
Key facts
| Proprietary names | MALACHITE GREEN OXLT,MALACHITE GREEN SOLUTION |
|---|---|
| Owner/operator | MilliporeSigma |
| Owner/operator number | 1216103 |
| Product codes | KJY |
| Device names | KJY - Malachite Green |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | EMD MILLIPORE CORPORATION, SIGMA-ALDRICH CORP., SIGMA-ALDRICH MANUFACTURING, LLC-H&H |
| Establishment registrations | 1937990, 1000138378, 3009432145 |
| FEI numbers | 1937990, 2244894, 1000138378 |
| Establishment operations | Complaint File Establishment, 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