Hellen Professional Services
Country not established
- Devices
- 2
What Hellen Professional Services makes
Hellen Professional Services produces diagnostic test kits for infectious disease detection, including the XENOSTRIP-TV for trichomonas diagnosis, and a myoglobin assay for cardiac marker analysis.
Their products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II, and are listed in the US regulatory database.
Catalogue
Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03 Ref K020226
Regimes: 510(k) Registry: 510(k)Quantech Myoglobin Assay Ref K981536
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hellen Professional Services have in the registry?
The registry currently lists 2 devices for Hellen Professional Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hellen Professional Services's devices?
Among its 2 most recently registered devices, Hellen Professional Services has devices listed in FDA 510(k) (2 devices).
What risk classes do Hellen Professional Services's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hellen Professional Services's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hellen Professional Services in the registry?
The most recently registered devices listed for Hellen Professional Services include XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 and QUANTECH MYOGLOBIN ASSAY.