Xenotope Diagnostics, Inc.
Country not established
- Devices
- 1
What Xenotope Diagnostics, Inc. makes
Xenotope Diagnostics, Inc. manufactures the XENOSTRIP-TV Trichomonas Cassette Test, a diagnostic device designed for the detection of *Trichomonas vaginalis* in clinical samples. The test is intended for in vitro use in laboratory settings to identify the presence of the parasite, aiding in the diagnosis of trichomoniasis.
The XENOSTRIP-TV Trichomonas Cassette Test is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xenotope Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Xenotope Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xenotope Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Xenotope Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Xenotope Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Xenotope Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Xenotope Diagnostics, Inc. in the registry?
The most recently registered devices listed for Xenotope Diagnostics, Inc. include XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01.