Globe Management Support, Inc.
JapanFDA applicant, unverified
- Devices
- 2
What Globe Management Support, Inc. makes
Globe Management Support, Inc. manufactures reagent systems for laboratory use, including the RF-LATEX SEIKEN REAGENT SYSTEM and the CRP-LATEX SEIKEN XR REAGENT SYSTEM. These products are designed for immunoturbidimetric assays, enabling quantitative measurement of specific analytes in serum or plasma samples, such as rheumatoid factor and C-reactive protein.
The company’s reagent systems are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Rf-Latex Seiken Reagent System Ref K960703
Regimes: 510(k) Registry: 510(k)Crp-Latex Seiken Xr Reagent System Ref K960702
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Globe Management Support, Inc. have in the registry?
The registry currently lists 2 devices for Globe Management Support, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Globe Management Support, Inc.'s devices?
Among its 2 most recently registered devices, Globe Management Support, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Globe Management Support, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Globe Management Support, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Globe Management Support, Inc. in the registry?
The most recently registered devices listed for Globe Management Support, Inc. include RF-LATEX SEIKEN REAGENT SYSTEM and CRP-LATEX SEIKEN XR REAGENT SYSTEM.