Eldan Technologies, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Eldan Technologies, Ltd. makes
Eldan Technologies, Ltd. manufactures the ROTA-DAN RAPID ROTAVIRUS EIA KIT, an in vitro diagnostic test designed for the detection of rotavirus antigens in fecal samples.
The company’s portfolio is regulated under FDA’s Class I device classification and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Rota-Dan Rapid Rotavirus Eia Kit Ref K951208
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eldan Technologies, Ltd. have in the registry?
The registry currently lists 1 device for Eldan Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eldan Technologies, Ltd.'s devices?
Among its 1 most recently registered device, Eldan Technologies, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Eldan Technologies, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Eldan Technologies, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Eldan Technologies, Ltd. in the registry?
The most recently registered devices listed for Eldan Technologies, Ltd. include ROTA-DAN RAPID ROTAVIRUS EIA KIT.