Immunodiagnostics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Immunodiagnostics, Ltd. makes
Immunodiagnostics, Ltd. manufactures the Gamma-B Anti-DS DNA Kit, a laboratory diagnostic test used to measure antibodies against double-stranded DNA (anti-DS DNA). The kit includes optional controls for quality assurance in serological testing, primarily for autoimmune disease monitoring.
The Gamma-B Anti-DS DNA Kit is classified as a Class II medical device under FDA regulations and requires a 510(k) clearance. The company is based in the United States.
Catalogue
The Gamma-B Anti-Ds Dna Kit & Optional Controls Ref K872085
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immunodiagnostics, Ltd. have in the registry?
The registry currently lists 1 device for Immunodiagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immunodiagnostics, Ltd.'s devices?
Among its 1 most recently registered device, Immunodiagnostics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Immunodiagnostics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Immunodiagnostics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immunodiagnostics, Ltd. in the registry?
The most recently registered devices listed for Immunodiagnostics, Ltd. include THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS.