FDA device listing
Microtest M4RT Transport,R12505 M4RT tube,R12506 M4RT tube,R12552 M4RT kit,R12565 M4RT Kit w/Traditional-Tipped Flocked…
FDA device listing 1895999506 · Thermo Fisher Scientific
Key facts
| Proprietary names | Microtest M4RT Transport,R12505 M4RT tube,R12506 M4RT tube,R12552 M4RT kit,R12565 M4RT Kit w/Traditional-Tipped Flocked Swab,R12566 M4RT MicroTip Flock Swab Kit PK/100,R12578 M4RT Universal Kit,R12587 M4RT Tube PK/72,R12588 M4RT KIT w/ FLOCKED SWAB PK/100,R12591 M4RT w/o beads 72/pk,R12592 M4RT kit w/o beads w/ flocked swab,R12593 M4RT kit w/o beads,R12599 M4RT kit,R12700 M4RT w/o beads,R12701… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K921472 |
| Product codes | JSM |
| Device names | JSM - Culture Media, Non-Propagating Transport |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2390 |
| Review panels | Microbiology |
| Registered establishments | REMEL, INC. |
| Establishment registrations | 1924669 |
| FEI numbers | 1924669 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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