Transmed, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Transmed, Inc. makes
Transmed, Inc. manufactures in vitro diagnostic kits for the rapid detection of multiple drugs of abuse using immunochromatographic technology. These include devices such as the CSI, REF, MICROTYNE UNIT, and CHALLENGER #450, which are designed for clinical use to screen for various substances in biological samples.
The company's devices are classified as Class II medical devices and are listed in the FDA's 510(k) premarket notification and Unique Device Identification (UDI) systems. Transmed, Inc. is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Microtyne Unit Ref K760913
Regimes: 510(k) Registry: 510(k)Belzer-Mps Ref K972066
Regimes: 510(k) Registry: 510(k)Challenger #450 Ref K830519
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Transmed, Inc. have in the registry?
The registry currently lists 10 devices for Transmed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Transmed, Inc.'s devices?
Among its 10 most recently registered devices, Transmed, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Transmed, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Transmed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Transmed, Inc. in the registry?
The most recently registered devices listed for Transmed, Inc. include CSI CSI-CUP-1144A3, REF REF-EWCUP-264, CSI CSI-CUP-1145S and CSI CSI-CUP-1144.