FDA device listing
Presage ST2 Assay Kit, Presage ST2 Assay Kit Controls
FDA device listing 1596072103 · BIOCHECK, INC.
Key facts
| Proprietary names | Presage ST2 Assay Kit, Presage ST2 Assay Kit Controls |
|---|---|
| Owner/operator | BIOCHECK, INC. |
| Owner/operator number | 9033543 |
| Product codes | JJX, OYG |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), OYG - St2 Assay |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1117, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | DRG INSTRUMENTS GMBH |
| Establishment registrations | 3002800697 |
| FEI numbers | 3002800697 |
| 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