FDA device listing
HSV-1 IgM ELISA
FDA device listing 1761640156 · BIOCHECK, INC.
Key facts
| Proprietary names | HSV-1 IgM ELISA |
|---|---|
| Owner/operator | BIOCHECK, INC. |
| Owner/operator number | 9033543 |
| Product codes | MXJ |
| Device names | MXJ - Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3305 |
| Review panels | Microbiology |
| Registered establishments | DRG INSTRUMENTS GMBH, DRG International, Inc. |
| Establishment registrations | 2245285, 3002800697 |
| FEI numbers | 2245285, 3002800697 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| 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