FDA device listing
CL AIA-PACK cTnI Adjuster Set,CL AIA-PACK cTnI Test Cup,ST AIA-PACK cTnI 3rd-Gen,ST AIA-PACK cTnI 3rd-Gen Sample…
FDA device listing 1894505847 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | CL AIA-PACK cTnI Adjuster Set,CL AIA-PACK cTnI Test Cup,ST AIA-PACK cTnI 3rd-Gen,ST AIA-PACK cTnI 3rd-Gen Sample Diluting Solution |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Product codes | MMI |
| Device names | MMI - Immunoassay Method, Troponin Subunit |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1215 |
| Review panels | Clinical Chemistry |
| Registered establishments | TOSOH AIA, INC., TOSOH CORP. |
| Establishment registrations | 8031673, 9612316 |
| FEI numbers | 2967, 3002808328 |
| Establishment operations | Foreign Exporter, 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