Northumbria Biologicals, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Northumbria Biologicals, Ltd. makes
Northumbria Biologicals, Ltd. manufactures the AntigenZ Chlamydia diagnostic test, a rapid antigen detection device for identifying *Chlamydia trachomatis* infections in clinical samples.
The AntigenZ Chlamydia 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.
Catalogue
Antigenz Chlamydia Ref K905402
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Northumbria Biologicals, Ltd. have in the registry?
The registry currently lists 1 device for Northumbria Biologicals, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Northumbria Biologicals, Ltd.'s devices?
Among its 1 most recently registered device, Northumbria Biologicals, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Northumbria Biologicals, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Northumbria Biologicals, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Northumbria Biologicals, Ltd. in the registry?
The most recently registered devices listed for Northumbria Biologicals, Ltd. include ANTIGENZ CHLAMYDIA.