FDA device listing
ZYMUTEST HIA IGGAM-RK040D,ZYMUTEST HIA IGG AND Z,ZYMUTEST HIA IGG- RK040A,ZYMUTEST HIA MONOSTRIP IGGAM-RK041D,ZYMUTEST…
FDA device listing 1342298611 · HYPHEN BIOMED
Key facts
| Proprietary names | ZYMUTEST HIA IGGAM-RK040D,ZYMUTEST HIA IGG AND Z,ZYMUTEST HIA IGG- RK040A,ZYMUTEST HIA MONOSTRIP IGGAM-RK041D,ZYMUTEST HIA MONOSTRIP IGG-RK041A |
|---|---|
| Owner/operator | HYPHEN BIOMED |
| Owner/operator number | 9067801 |
| Premarket submissions | K071255 |
| Product codes | LCO |
| Device names | LCO - Platelet Factor 4 Radioimmunoassay |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7695 |
| Review panels | Hematology |
| Registered establishments | HYPHEN BIOMED SASU |
| Establishment registrations | 3004434070 |
| FEI numbers | 3004434070 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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