Diagnology, Ltd.
Country not established
- Devices
- 1
What Diagnology, Ltd. makes
Diagnology, Ltd. manufactures the POCKIT HSV 2 RAPID TEST, a diagnostic device designed for the rapid detection of herpes simplex virus type 2 (HSV-2) antibodies in human blood samples. The test is intended for point-of-care or near-patient use to provide results within minutes, aiding in the early identification of HSV-2 infection.
The POCKIT HSV 2 RAPID TEST is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States, and the device is listed in the FDA’s 510(k) registry.
Catalogue
Pockit Hsv 2 Rapid Test Ref K983886
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnology, Ltd. have in the registry?
The registry currently lists 1 device for Diagnology, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnology, Ltd.'s devices?
Among its 1 most recently registered device, Diagnology, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Diagnology, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Diagnology, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnology, Ltd. in the registry?
The most recently registered devices listed for Diagnology, Ltd. include POCKIT HSV 2 RAPID TEST.