Mrl Diagnostics
Country not established
- Devices
- 7
What Mrl Diagnostics makes
Mrl Diagnostics produces serological assays for infectious disease testing, including immunofluorescent and ELISA-based tests for Epstein-Barr virus, Lyme disease (*Borrelia burgdorferi*), and herpes simplex virus (HSV-1 and HSV-2). Their portfolio also includes Western blot assays for Lyme disease and HSV differentiation tests.
The company’s products are classified under FDA device classes I and II, with regulatory submissions recorded via 510(k) pathways. These assays are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Hsv-1 Elisa Igg, Model EL0910G Ref K993754
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Hsv-2 Elisa Igg, Model EL0920G Ref K993724
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mrl Diagnostics have in the registry?
The registry currently lists 7 devices for Mrl Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mrl Diagnostics's devices?
Among its 7 most recently registered devices, Mrl Diagnostics has devices listed in FDA 510(k) (7 devices).
What risk classes do Mrl Diagnostics's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Mrl Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mrl Diagnostics in the registry?
The most recently registered devices listed for Mrl Diagnostics include EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY, LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M), HSV-1 ELISA IGG, MODEL EL0910G and HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G.