Mardx, Inc.
Country not established
- Devices
- 1
What Mardx, Inc. makes
Mardx, Inc. manufactures the MARDX Lyme Disease Immunofluorescence Assay (IgM) Test System, a diagnostic device used for detecting IgM antibodies in serum or plasma samples to aid in the identification of Lyme disease.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The device is listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Mardx Lyme Disease Ifa (Igm) Test System Ref K894609
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mardx, Inc. have in the registry?
The registry currently lists 1 device for Mardx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mardx, Inc.'s devices?
Among its 1 most recently registered device, Mardx, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mardx, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mardx, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mardx, Inc. in the registry?
The most recently registered devices listed for Mardx, Inc. include MARDX LYME DISEASE IFA (IGM) TEST SYSTEM.