FDA device listing
Giardia/Cryptosporidium Combo Stool Antigen Detection ELISA,GIARDIA STOOL ANTIGEN ELISA
FDA device listing 1462224344 · IVD RESEARCH, LLC.
Key facts
| Proprietary names | Giardia/Cryptosporidium Combo Stool Antigen Detection ELISA,GIARDIA STOOL ANTIGEN ELISA |
|---|---|
| Owner/operator | IVD RESEARCH, LLC. |
| Owner/operator number | 9034173 |
| Product codes | MHI |
| Device names | MHI - Giardia Spp. |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3220 |
| Review panels | Microbiology |
| Registered establishments | IVD RESEARCH, LLC. |
| Establishment registrations | 2031468 |
| FEI numbers | 3002023342 |
| Establishment operations | 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