Diapharma Group, Inc.
Country not established FDA establishment FEI 3000719074
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What Diapharma Group, Inc. makes
Diapharma Group, Inc. manufactures in vitro diagnostic (IVD) kits for measuring coagulation factor X using chromogenic assays. These products are designed for laboratory use to quantify Factor X levels in blood samples, supporting diagnostic testing for coagulation disorders.
The company’s coagulation factor X IVD kits are classified as Class II devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer operates from the United States.
Catalogue
- GUDID
Diapharma Factor X Kit Ref K040362
510(k) 510(k)
Company details
- FDA FEI number
- 3000719074
- Address
- 8948 Beckett Rd, WEST CHESTER, OH, 45069
Frequently asked questions
How many devices does DIAPHARMA GROUP, INC. have in the registry?
The registry currently lists 2 devices for DIAPHARMA GROUP, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list DIAPHARMA GROUP, INC.'s devices?
Among its 2 most recently registered devices, DIAPHARMA GROUP, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DIAPHARMA GROUP, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for DIAPHARMA GROUP, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from DIAPHARMA GROUP, INC. in the registry?
The most recently registered devices listed for DIAPHARMA GROUP, INC. include Diapharma Factor X Kit DPGFX and DIAPHARMA FACTOR X KIT.