Dakocytomation, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Dakocytomation, Ltd. makes
Dakocytomation, Ltd. manufactures the IDEIA PCE Chlamydia, a diagnostic test designed for detecting *Chlamydia trachomatis* infections using polymerase chain reaction (PCR) technology.
The IDEIA PCE Chlamydia is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Ideia Pce Chlamydia Ref K033865
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dakocytomation, Ltd. have in the registry?
The registry currently lists 1 device for Dakocytomation, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dakocytomation, Ltd.'s devices?
Among its 1 most recently registered device, Dakocytomation, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Dakocytomation, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dakocytomation, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dakocytomation, Ltd. in the registry?
The most recently registered devices listed for Dakocytomation, Ltd. include IDEIA PCE CHLAMYDIA.