Haemachem, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Haemachem, Inc. makes
Haemachem, Inc. manufactures diagnostic reagents for coagulation testing, including bovine thrombin and human thrombin for laboratory use, as well as quantitative assays for heparin and fibrinogen levels in plasma. It also supplies bovine and human Factor Xa for research and clinical applications.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. Haemachem, Inc. is based in the United States.
Catalogue
Bovine Thrombin, Human Thrombin Ref K841956
Regimes: 510(k) Registry: 510(k)Heptest-A Quantitative Heparin In Plasma Assay Ref K853239
Regimes: 510(k) Registry: 510(k)Fibrinotest(Tm) - Fibrinogen Assay Ref K903874
Regimes: 510(k) Registry: 510(k)Bovine Factor Xa-Human Factor Xa Ref K841957
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haemachem, Inc. have in the registry?
The registry currently lists 4 devices for Haemachem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haemachem, Inc.'s devices?
Among its 4 most recently registered devices, Haemachem, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Haemachem, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Haemachem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haemachem, Inc. in the registry?
The most recently registered devices listed for Haemachem, Inc. include BOVINE THROMBIN, HUMAN THROMBIN, HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY, FIBRINOTEST(TM) - FIBRINOGEN ASSAY and BOVINE FACTOR XA-HUMAN FACTOR XA.