Cardiovascular Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Cardiovascular Diagnostics, Inc. makes
Cardiovascular Diagnostics, Inc. manufactures point-of-care coagulation test cards and analyzers, including heparin management test cards, prothrombin time (PT) and activated partial thromboplastin time (aPTT) test cards, and thrombolytic assessment system controls. Their portfolio also includes specialized test systems for monitoring enoxaparin and heparin levels, as well as data acquisition software for test results, such as the TAS Analyzer and TRAQS system. Additional products include rapid titration and protamine response tests for heparin management, designed for clinical and emergency settings.
The company’s devices are classified under FDA Class II and are authorised through the 510(k) pathway in the United States. Their products are listed in the FDA’s 510(k) registry, reflecting compliance with regulatory requirements for coagulation monitoring systems. The company operates from the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Cardiovascular Diagnostics, Inc. have in the registry?
The registry currently lists 13 devices for Cardiovascular Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiovascular Diagnostics, Inc.'s devices?
Among its 13 most recently registered devices, Cardiovascular Diagnostics, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Cardiovascular Diagnostics, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Cardiovascular Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiovascular Diagnostics, Inc. in the registry?
The most recently registered devices listed for Cardiovascular Diagnostics, Inc. include (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT, ENOXAPARIN TEST CARD, HEPARIN MANAGEMENT TEST CARD; HMT CARD and THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS.