FDA device listing
Multi-Analyte Controls, All Kinds (Assayed)
FDA device listing 1315192719 · GroPep Bioreagents Pty Ltd
Key facts
| Owner/operator | GroPep Bioreagents Pty Ltd |
|---|---|
| Owner/operator number | 10053206 |
| Product codes | JJY |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | GROPEP BIOREAGENTS PTY LTD |
| Establishment registrations | 3008723200 |
| FEI numbers | 3008723200 |
| Establishment operations | Contract 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