Bhp Diagnostix, Inc.
United StatesFDA applicant, unverified
- Devices
- 25
What Bhp Diagnostix, Inc. makes
Bhp Diagnostix, Inc. manufactures blood chemistry analyzers, including the SERACON-SRI, SERACON CAL, and SERACON TM SR III series for serum chemistry testing, as well as hematology analyzers like the QUANTICEL HHR with human reference panels for platelet and cell counting. Additional products include specialized reference controls such as SERACON CT REFERENCE and SERACON HDL for specific biochemical assays.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported through 510(k) clearances. These products are listed in the U.S. FDA registry, adhering to U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 25 devicesFrequently asked questions
How many devices does Bhp Diagnostix, Inc. have in the registry?
The registry currently lists 25 devices for Bhp Diagnostix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bhp Diagnostix, Inc.'s devices?
Among its 25 most recently registered devices, Bhp Diagnostix, Inc. has devices listed in FDA 510(k) (25 devices).
What risk classes do Bhp Diagnostix, Inc.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Bhp Diagnostix, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bhp Diagnostix, Inc. in the registry?
The most recently registered devices listed for Bhp Diagnostix, Inc. include SERACON-SRI (PROD. # D029, SERACON CAL D025, QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS and SERACON TM SR III.