Unotech Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Unotech Diagnostics, Inc. makes
Unotech Diagnostics, Inc. manufactures urine-based pregnancy test devices, including the ACCUSTRIP HCG-URINE (Model HCG-002) and ACCUTEST HCG-URINE, as well as combination test kits like the ACCUTEST HCG-COMBO (Models HCG-004 and HCG-005). These products detect human chorionic gonadotropin (hCG) in urine samples to confirm pregnancy.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in the United States, where they are subject to compliance with FDA requirements for diagnostic tests.
Catalogue
Accustrip Hcg-Urine Model Number Hcg-002 Ref K981838
510(k) 510(k)- 510(k) 510(k)
Accutest Hcg-Urine Ref K971886
510(k) 510(k)
Frequently asked questions
How many devices does Unotech Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Unotech Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unotech Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Unotech Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Unotech Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Unotech Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unotech Diagnostics, Inc. in the registry?
The most recently registered devices listed for Unotech Diagnostics, Inc. include ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002, ACCUTEST HCG-COMBO MODEL, HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 and ACCUTEST HCG-URINE.