Cel Labs Pty, Ltd.
Country not established
- Devices
- 1
What Cel Labs Pty, Ltd. makes
Cel Labs Pty, Ltd. manufactures the Chlamydia-CEL Immunofluorescence (IF) Test, a diagnostic device used for detecting Chlamydia trachomatis infections through immunofluorescence microscopy.
This product is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Chlamydia-Cel Immunofluorenscence (If) Test Ref K901243
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cel Labs Pty, Ltd. have in the registry?
The registry currently lists 1 device for Cel Labs Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cel Labs Pty, Ltd.'s devices?
Among its 1 most recently registered device, Cel Labs Pty, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Cel Labs Pty, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cel Labs Pty, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cel Labs Pty, Ltd. in the registry?
The most recently registered devices listed for Cel Labs Pty, Ltd. include CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST.