Handylab, Inc.
Country not established
- Devices
- 1
What Handylab, Inc. makes
Handylab, Inc. manufactures diagnostic instruments and reagents for molecular testing, including a point-of-care instrument (JAGUAR) for group B streptococcus (GBS) assays, as well as DNA extraction strips and extraction reagents (E3) designed for sample preparation in laboratory settings.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The portfolio is intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Handylab, Inc. have in the registry?
The registry currently lists 1 device for Handylab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Handylab, Inc.'s devices?
Among its 1 most recently registered device, Handylab, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Handylab, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Handylab, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Handylab, Inc. in the registry?
The most recently registered devices listed for Handylab, Inc. include HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB.