Exact Diagnostics
United Statesfrom the FDA registration address FDA FEI 3011926203
Exact Diagnostics is a medical device manufacturer, with 94 devices listed in FDA GUDID (FDA Class I and II) as of 13 Nov 2026.
- Devices
- 94
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 94
- Device classes
- FDA Class I 64
- FDA Class II 30
- Identifiers
- FDA FEI 3011926203
At a glance
Market reach
- United States
- FDA FEI
What Exact Diagnostics makes
Exact Diagnostics manufactures in vitro diagnostic (IVD) controls and calibrators for various infectious diseases, including PCR/NAT negative controls, nucleic acid tests for Hepatitis C, Hepatitis B, Herpes simplex virus 1 & 2, Human papillomavirus, HIV1, and Cytomegalovirus, as well as multiple-genus respiratory virus controls.
The company's portfolio includes Class I and Class I IVD devices, which are listed in the FDA UDI registry.
Catalogue
Search and filter all 94 devicesShowing 1-50 of 94
Company details
- FDA FEI number
- 3011926203
- Address
- 100 South Jones Street Suite #100, Fort Worth, TX, 76104
Frequently asked questions
How many devices does Exact Diagnostics have in the registry?
The registry currently lists 94 devices for Exact Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exact Diagnostics's devices?
Among its 50 most recently registered devices, Exact Diagnostics has devices listed in FDA GUDID (50 devices).
What risk classes do Exact Diagnostics's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Exact Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Exact Diagnostics in the registry?
The most recently registered devices listed for Exact Diagnostics include Exact Diagnostics BABRC, Exact Diagnostics HSV2L101, Exact Diagnostics HPVP200 and Exact Diagnostics HIVL101.