Lehnus & Associates Consulting
Country not established
- Devices
- 2
What Lehnus & Associates Consulting makes
Lehnus & Associates Consulting manufactures in-vitro diagnostic devices, including a pregnancy rapid test and a cortisol immunoassay test kit for laboratory use. These products are designed for point-of-care and clinical laboratory settings to detect pregnancy hormones and measure cortisol levels, respectively.
The company’s diagnostic devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s regulatory database and comply with U.S. in-vitro diagnostic device requirements.
Catalogue
Pregnancy One Step Rapid Test Ref K103574
Regimes: 510(k) Registry: 510(k)Ibl Cortisol Lia Test Kit Ref K052359
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lehnus & Associates Consulting have in the registry?
The registry currently lists 2 devices for Lehnus & Associates Consulting. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lehnus & Associates Consulting's devices?
Among its 2 most recently registered devices, Lehnus & Associates Consulting has devices listed in FDA 510(k) (2 devices).
What risk classes do Lehnus & Associates Consulting's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Lehnus & Associates Consulting's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lehnus & Associates Consulting in the registry?
The most recently registered devices listed for Lehnus & Associates Consulting include PREGNANCY ONE STEP RAPID TEST and IBL CORTISOL LIA TEST KIT.