Biotron U.S.A., Inc.
Country not established
- Devices
- 1
What Biotron U.S.A., Inc. makes
Biotron U.S.A., Inc. manufactures the BIOTROL HDL cholesterol precipitation reagent, a diagnostic reagent used in laboratory testing to separate high-density lipoprotein (HDL) cholesterol from other serum lipoproteins for accurate measurement.
This product is classified as a Class I medical device under U.S. regulations and is listed in the FDA’s 510(k) database. The company operates from the United States.
Catalogue
Biotrol Hdl Cholesterol Precipitation Reagent Ref K904184
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotron U.S.A., Inc. have in the registry?
The registry currently lists 1 device for Biotron U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotron U.S.A., Inc.'s devices?
Among its 1 most recently registered device, Biotron U.S.A., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Biotron U.S.A., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biotron U.S.A., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Biotron U.S.A., Inc. in the registry?
The most recently registered devices listed for Biotron U.S.A., Inc. include BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT.