FDA device listing
DR0500G Oxoid Reaction Cards,DR0586G Latex Grouping Reagent A,DR0587G Latex Grouping Reagent B,DR0588G Latex Grouping…
FDA device listing 1304508203 · Thermo Fisher Scientific
Key facts
| Proprietary names | DR0500G Oxoid Reaction Cards,DR0586G Latex Grouping Reagent A,DR0587G Latex Grouping Reagent B,DR0588G Latex Grouping Reagent C,DR0589G Latex Grouping Reagent D,DR0590G Latex Grouping Reagent F,DR0591G Latex Grouping Reagent G,DR0700M PathoDxtra Strep Grouping Kit (60 tests),DR0701G PATHODXTRA STREP GROUP A LATEX,DR0702G PATHODXTRA STREP GROUP B LATEX,DR0703G PATHODXTRA STREP GROUP C LATEX,DR0704G… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | GTZ |
| Device names | GTZ - Antisera, All Groups, Streptococcus Spp. |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3740 |
| 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