FDA device listing
IH-Papain
FDA device listing 2058150148 · DiaMed GmbH (Bio-Rad Laboratories)
Key facts
| Proprietary names | IH-Papain |
|---|---|
| Owner/operator | DiaMed GmbH (Bio-Rad Laboratories) |
| Owner/operator number | 10032616 |
| Product codes | KSK |
| Device names | KSK - Solution, Stabilized Enzyme |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.9400 |
| Review panels | Hematology |
| Registered establishments | BIO-RAD MEDICAL DIAGNOSTICS GMBH, DiaMed GmbH |
| Establishment registrations | 9610824, 3004910133 |
| FEI numbers | 3002806595, 3004910133 |
| 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