Third Wave Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Third Wave Technologies, Inc. makes
Third Wave Technologies, Inc. manufactures molecular diagnostic tests, including the INPLEX CF molecular test for cystic fibrosis detection and the INVADER UGT1A1 molecular assay for genetic variant analysis.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Inplex Cf Molecular Test Ref K063787
Regimes: 510(k) Registry: 510(k)Invader UGT1A1 Molecular Assay Ref K051824
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Third Wave Technologies, Inc. have in the registry?
The registry currently lists 2 devices for Third Wave Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Third Wave Technologies, Inc.'s devices?
Among its 2 most recently registered devices, Third Wave Technologies, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Third Wave Technologies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Third Wave Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Third Wave Technologies, Inc. in the registry?
The most recently registered devices listed for Third Wave Technologies, Inc. include INPLEX CF MOLECULAR TEST and INVADER UGT1A1 MOLECULAR ASSAY.