True Diagnostics, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3027500452
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What True Diagnostics, Inc. makes
True Diagnostics, Inc. manufactures early result pregnancy tests, including digital and cassette/midstream formats. These devices detect human chorionic gonadotropin (hCG) to provide rapid pregnancy confirmation within minutes.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. They are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
VeriClear Digital Early Result Pregnancy Test Ref K182328
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3027500452
- Address
- 5919 Farnsworth Ct, Carlsbad, CA, 92008
Frequently asked questions
How many devices does TRUE DIAGNOSTICS, INC. have in the registry?
The registry currently lists 2 devices for TRUE DIAGNOSTICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TRUE DIAGNOSTICS, INC.'s devices?
Among its 2 most recently registered devices, TRUE DIAGNOSTICS, INC. has devices listed in FDA 510(k) (2 devices).
What risk classes do TRUE DIAGNOSTICS, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for TRUE DIAGNOSTICS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from TRUE DIAGNOSTICS, INC. in the registry?
The most recently registered devices listed for TRUE DIAGNOSTICS, INC. include VeriClear Digital Early Result Pregnancy Test and TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format).