Labsystems, Inc.
Country not established
- Devices
- 17
What Labsystems, Inc. makes
Labsystems, Inc. manufactures enzyme immunoassay (EIA) test kits for detecting IgG and IgM antibodies to rubella and toxoplasma, including modified versions of these tests. The company also produces a chemistry analyzer for laboratory use and a tilt/reduced shear semi-recline seating system for patient support. Diagnostic products focus on infectious disease markers, while the seating system is designed for clinical or mobility applications.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are listed in the U.S. Food and Drug Administration’s regulatory database. The manufacturer is based in the United States.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Labsystems, Inc. have in the registry?
The registry currently lists 17 devices for Labsystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Labsystems, Inc.'s devices?
Among its 17 most recently registered devices, Labsystems, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Labsystems, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Labsystems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Labsystems, Inc. in the registry?
The most recently registered devices listed for Labsystems, Inc. include RUBELLA IGG EIA TEST KIT, RESUBMITTED FECATWIN SENSITIVE - FECA-EIA, LABSYSTEMS FP-901 CHEMISTRY ANALYZER and RUBELLA IGM EIA TEST KIT.