FDA device listing
DrySpot E. coli 0157 Latex Test,DrySpot E. coli Seroscreen Kit,DrySpot Serocheck O103 Kit,DrySpot Serocheck O111…
FDA device listing 1283554404 · Thermo Fisher Scientific
Key facts
| Proprietary names | DrySpot E. coli 0157 Latex Test,DrySpot E. coli Seroscreen Kit,DrySpot Serocheck O103 Kit,DrySpot Serocheck O111 Kit,DrySpot Serocheck O128 Kit,DrySpot Serocheck O145 Kit,DrySpot Serocheck O26 Kit,DrySpot Serocheck O91 Kit,Escherichia ColiI O157 Latex Test |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | GNA |
| Device names | GNA - Antisera, All Types, Escherichia Coli |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3255 |
| Review panels | Microbiology |
| Registered establishments | OXOID, LTD., REMEL EUROPE LTD |
| Establishment registrations | 8010096, 3003750284 |
| FEI numbers | 3003750284, 3006224287 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Specification Developer |
| 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