Biotrack, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
What Biotrack, Inc. makes
Biotrack, Inc. manufactures diagnostic test cartridges and reagent cartridges for clinical laboratory testing, including products for phenytoin, theophylline, hemoglobin, ALT, prothrombin time (PT/INR), activated partial thromboplastin time (APTT), and therapeutic drug monitoring. The company also produces quality control materials and monitors, such as the Biotrack PDS Monitor and Biotrack Monitor, which are used with its reagent cartridges for coagulation and drug level testing.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s 510(k) premarket notification database. Biotrack, Inc. is based in the United States.
Catalogue
Search and filter all 16 devicesFrequently asked questions
How many devices does Biotrack, Inc. have in the registry?
The registry currently lists 16 devices for Biotrack, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotrack, Inc.'s devices?
Among its 16 most recently registered devices, Biotrack, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Biotrack, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Biotrack, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotrack, Inc. in the registry?
The most recently registered devices listed for Biotrack, Inc. include BIOTRACK PHENYTOIN TEST CARTRIDGE, BIOTRACK THEOPHYLLINE QUALITY CONTROLS, BIOTRACK HEMOGLOBIN TEST CARTRIDGE and BIOTRACK ALT TEST CARTRIDGE.