Jellox Biotech, Inc.
TaiwanFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Jellox Biotech, Inc. makes
Jellox Biotech, Inc. develops digital pathology software, including the MetaLite DX platform, designed for analyzing and managing histopathological images in a clinical or research setting.
The company’s portfolio is regulated as Class II medical devices under FDA 510(k) clearance requirements. The devices are listed in the FDA’s 510(k) database. Jellox Biotech, Inc. is based in the United States.
Catalogue
- GUDID
MetaLite DX Digital Pathology Software Ref K240303
510(k) 510(k)
Company details
- DUNS number
- 658741023
- [email protected]
- Phone
- +8866583058
FDA establishments
- Jellox Biotech Inc. Hsinchu County Hsinchu(County) · TW FEI 3026040791
Frequently asked questions
How many devices does Jellox Biotech, Inc. have in the registry?
The registry currently lists 2 devices for Jellox Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jellox Biotech, Inc.'s devices?
Among its 2 most recently registered devices, Jellox Biotech, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jellox Biotech, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Jellox Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jellox Biotech, Inc. in the registry?
The most recently registered devices listed for Jellox Biotech, Inc. include JelloX 1.2.1 and MetaLite DX Digital Pathology Software.
Which FDA establishments are linked to Jellox Biotech, Inc.?
1 FDA establishment is linked to Jellox Biotech, Inc. in the registry; they are listed on the company page.