Helena Laboratories UK, Ltd.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Helena Laboratories UK, Ltd. makes
Helena Laboratories UK, Ltd. manufactures immunodisplacement assay kits, specifically the Helena V8 series, designed for laboratory use in measuring concentrations of substances such as proteins or hormones in biological samples.
The company’s immunodisplacement kits are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
The Helena V8 Immunodisplacement Kit Ref K111369
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Helena Laboratories UK Ltd Gateshead Newcastle upon Tyne · GB FEI 3009736003
Frequently asked questions
How many devices does Helena Laboratories Uk, Ltd. have in the registry?
The registry currently lists 1 device for Helena Laboratories Uk, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helena Laboratories Uk, Ltd.'s devices?
Among its 1 most recently registered device, Helena Laboratories Uk, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Helena Laboratories Uk, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Helena Laboratories Uk, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Helena Laboratories Uk, Ltd. in the registry?
The most recently registered devices listed for Helena Laboratories Uk, Ltd. include THE HELENA V8 IMMUNODISPLACEMENT KIT.
Which FDA establishments are linked to Helena Laboratories Uk, Ltd.?
1 FDA establishment is linked to Helena Laboratories Uk, Ltd. in the registry; they are listed on the company page.