Gelman Instrument Co.
Country not established
- Devices
- 11
What Gelman Instrument Co. makes
Gelman Instrument Co. manufactures radial immunodiffusion kits for quantifying specific proteins and antigens, including alpha-1 antitrypsin, immunoglobulins (IgG, IgM), haptoglobin, transferrin, and complement components (C3). The company also supplies reagent sets for lipoprotein electrophoresis and alkaline phosphatase isozyme analysis, alongside automated densitometers for measuring results.
These products are regulated under FDA’s Class I and Class II device classifications, with relevant submissions recorded in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Gelman Instrument Co. have in the registry?
The registry currently lists 11 devices for Gelman Instrument Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gelman Instrument Co.'s devices?
Among its 11 most recently registered devices, Gelman Instrument Co. has devices listed in FDA 510(k) (11 devices).
What risk classes do Gelman Instrument Co.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Gelman Instrument Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gelman Instrument Co. in the registry?
The most recently registered devices listed for Gelman Instrument Co. include RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT, RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M, RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN and RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN.