Quantai Biotronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Quantai Biotronics, Inc. makes
Quantai Biotronics, Inc. manufactures diagnostic reagent strips and test films for blood glucose monitoring and urine analysis, including urine glucose and general reagent strips.
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
Quick Check 3 Film Ref K903191
Regimes: 510(k) Registry: 510(k)Quantai Ug Reagent Strip Ref K893661
Regimes: 510(k) Registry: 510(k)Quantai Bg(Tm) Reagent Strip Ref K880703
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quantai Biotronics, Inc. have in the registry?
The registry currently lists 3 devices for Quantai Biotronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quantai Biotronics, Inc.'s devices?
Among its 3 most recently registered devices, Quantai Biotronics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Quantai Biotronics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Quantai Biotronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quantai Biotronics, Inc. in the registry?
The most recently registered devices listed for Quantai Biotronics, Inc. include QUICK CHECK 3 FILM, QUANTAI UG REAGENT STRIP and QUANTAI BG(TM) REAGENT STRIP.