Isotypes, Inc.
Country not established
- Devices
- 1
What Isotypes, Inc. makes
Isotypes, Inc. manufactures enzyme immunoassay (EIA) kits designed for detecting human IgG subclasses in serum or plasma samples. These kits are intended for in vitro diagnostic use to quantify IgG1, IgG2, IgG3, and IgG4 levels, supporting clinical research and diagnostic applications.
The company’s portfolio is regulated under FDA’s Class II device classification, requiring premarket notification (510(k)) clearance. The devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Isotypes Human Igg Subclass Eia Kit Ref K920370
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isotypes, Inc. have in the registry?
The registry currently lists 1 device for Isotypes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isotypes, Inc.'s devices?
Among its 1 most recently registered device, Isotypes, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Isotypes, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Isotypes, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isotypes, Inc. in the registry?
The most recently registered devices listed for Isotypes, Inc. include ISOTYPES HUMAN IGG SUBCLASS EIA KIT.