Biotrol, USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 46
What Biotrol, USA, Inc. makes
Biotrol, USA, Inc. manufactures diagnostic reagents and assay kits for clinical laboratory testing, including UV-based bicarbonate (CO₂) measurement, enzyme-linked immunosorbent assays (ELISA) for toxoplasmosis, and biochemical tests for liver function (ALT/TGP), albumin, alkaline phosphatase, and creatine kinase (CK). The portfolio also covers electrolyte assays like magnesium (using Calmagite or other methods) and inorganic phosphorus, alongside amylase and control solutions for chemical pathology verification.
The company’s diagnostic products are classified under FDA’s Class I and Class II regulatory categories, with relevant devices listed via 510(k) premarket notifications. These products are intended for in vitro use in clinical laboratories and are subject to FDA oversight under the Federal Food, Drug, and Cosmetic Act. The manufacturer operates from the United States.
Catalogue
Search and filter all 46 devicesFrequently asked questions
How many devices does Biotrol, USA, Inc. have in the registry?
The registry currently lists 46 devices for Biotrol, USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotrol, USA, Inc.'s devices?
Among its 46 most recently registered devices, Biotrol, USA, Inc. has devices listed in FDA 510(k) (46 devices).
What risk classes do Biotrol, USA, Inc.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Biotrol, USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotrol, USA, Inc. in the registry?
The most recently registered devices listed for Biotrol, USA, Inc. include BIOTROL BICARBONATE (CO2) UV HP), BIOTROL AMYLASE CNPG3, BIOTROL MAGNESIUM (MAGON) and BIOTROL ALT/TGP MONOREACTIF.