Immuntech A/S
DenmarkFDA applicant, unverified
- Devices
- 1
What Immuntech A/S makes
Immuntech A/S manufactures the SCANLISA Human CRP ELISA Kit, a diagnostic test designed to quantify C-reactive protein levels in human serum or plasma using enzyme-linked immunosorbent assay (ELISA) technology.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance in the United States. The company is based in the US.
Catalogue
Scanlisa Human Crp Elisa Kit Ref K894573
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immuntech A/S have in the registry?
The registry currently lists 1 device for Immuntech A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immuntech A/S's devices?
Among its 1 most recently registered device, Immuntech A/S has devices listed in FDA 510(k) (1 device).
What risk classes do Immuntech A/S's devices fall under?
Among its 1 most recently registered device, the classes recorded for Immuntech A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immuntech A/S in the registry?
The most recently registered devices listed for Immuntech A/S include SCANLISA HUMAN CRP ELISA KIT.