Pro-Lab Diagnostics
Active in EUDAMEDCanadafrom SRN EUDAMED SRN CA-MF-000011305
- Devices
- 21
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Pro-Lab Diagnostics makes
Pro-Lab Diagnostics manufactures microbiological transport and enrichment media, including liquid Stuart medium, Amies medium with and without charcoal, and Amies medium with charcoal. Their portfolio also includes a latex agglutination test for detecting *E. coli* O157.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Search and filter all 21 devicesCompany details
- EUDAMED SRN
- CA-MF-000011305
- EUDAMED status
- Active
- EUDAMED registered name
- Pro-Lab Diagnostics Inc.
- Registered address
- 20, Mural Street, L4B 1K3, Richmond Hill, Canada
- Website
- www.pro-lab.com
- [email protected]
- Phone
- 1-800-268-2341
- PRRC contact
- Sajni Shah
Frequently asked questions
How many devices does Pro-Lab Diagnostics have in the registry?
The registry currently lists 21 devices for Pro-Lab Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pro-Lab Diagnostics's devices?
Among its 21 most recently registered devices, Pro-Lab Diagnostics has devices listed in EUDAMED (16 devices) and FDA 510(k) (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Pro-Lab Diagnostics's devices fall under?
Among its 21 most recently registered devices, the classes recorded for Pro-Lab Diagnostics's devices are Class I and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Pro-Lab Diagnostics in the registry?
The most recently registered devices listed for Pro-Lab Diagnostics include Bulk E.coli O157 Latex Reagent, Streptococcal Enzyme Group A Latex Reagent, C.difficile GDH Rapid Test Kit and Streptococcal Enzyme Group G Latex Reagent.