Kmi Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Kmi Diagnostics, Inc. makes
Kmi Diagnostics, Inc. manufactures in vitro diagnostic tests for hormone measurement, including assays for calcitonin, cortisol, testosterone, DHEA-S, progesterone, and 17β-estradiol. These tests are designed for laboratory use to quantify specific biomarkers in patient samples.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. They are listed in the FDA’s 510(k) database, reflecting their authorised diagnostic status in the United States.
Catalogue
Calcitonin Ref K990073
Regimes: 510(k) Registry: 510(k)Cortisol Lia Ref K010790
Regimes: 510(k) Registry: 510(k)Testoterone Elisa Ref K973900
Regimes: 510(k) Registry: 510(k)Dhea-S Ref K973897
Regimes: 510(k) Registry: 510(k)Progesterone Elisa Ref K973898
Regimes: 510(k) Registry: 510(k)17 B-Estradiol (Elisa) Ref K973901
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kmi Diagnostics, Inc. have in the registry?
The registry currently lists 6 devices for Kmi Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kmi Diagnostics, Inc.'s devices?
Among its 6 most recently registered devices, Kmi Diagnostics, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Kmi Diagnostics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Kmi Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kmi Diagnostics, Inc. in the registry?
The most recently registered devices listed for Kmi Diagnostics, Inc. include CALCITONIN, CORTISOL LIA, TESTOTERONE ELISA and DHEA-S.