Pacific Hemostasis
Country not established
- Devices
- 27
What Pacific Hemostasis makes
Pacific Hemostasis manufactures coagulation reference plasmas, including prothrombin reference plasma and immunodepleted factor V-deficient plasma under the brand ThrombosDreen, as well as control plasmas for laboratory testing. The company also produces reagents for coagulation assays, such as Thromboscreen thromboplastin-DS, APTT reagent, and kits for screening antithrombin III, fibrinogen, and glycosylated hemoglobin. Additional products include control plasmas for heparin level testing and abnormal coagulation profiles, alongside in vitro diagnostic devices like the Thromboscreen 200 and Thromboscreen 400C.
These devices are classified under FDA’s Class II regulatory category and are listed via 510(k) clearance. The company operates within the United States, adhering to US regulatory requirements for in vitro diagnostics.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Pacific Hemostasis have in the registry?
The registry currently lists 27 devices for Pacific Hemostasis. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacific Hemostasis's devices?
Among its 27 most recently registered devices, Pacific Hemostasis has devices listed in FDA 510(k) (27 devices).
What risk classes do Pacific Hemostasis's devices fall under?
Among its 27 most recently registered devices, the classes recorded for Pacific Hemostasis's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pacific Hemostasis in the registry?
The most recently registered devices listed for Pacific Hemostasis include PROTHROMBIN REFERENCE PLASMA (HUMAN), PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056), THROMBOSTRATE CONTROL PLASMAS and THROMBOSCREEN THROMBOPLASTIN-DS.