New Horizons Diagnostics Co.
Country not established
- Devices
- 10
What New Horizons Diagnostics Co. makes
New Horizons Diagnostics Co. manufactures diagnostic tests for infectious diseases, including tests for Neisseria gonorrhoeae, bacteriuria, syphilis, streptococcus A, and cholera, as well as reagents for serological testing and latex agglutination tests.
The company's devices are regulated in the US as Class I and Class II medical devices and are listed in the FDA 510(k) database. New Horizons Diagnostics Co. is based in the US.
Catalogue
Neisseria Gonorrhoeae Test Ref K820007
510(k) 510(k)Rapid Bacteriuria Screen (Rbs) Ref K862195
510(k) 510(k)Syphilis Serological Reagents Ref K871226
510(k) 510(k)Pyloriscreen Ref K925190
510(k) 510(k)Cholerascreen Ref K922432
510(k) 510(k)Rapid Colorimetric Direct Strep A Test Ref K874761
510(k) 510(k)Improved Gono Gen Ref K821362
510(k) 510(k)Latex Agglutination Test Ref K851132
510(k) 510(k)- 510(k) 510(k)
Cholera Smart(Tm) Ref K932622
510(k) 510(k)
Frequently asked questions
How many devices does New Horizons Diagnostics Co. have in the registry?
The registry currently lists 10 devices for New Horizons Diagnostics Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Horizons Diagnostics Co.'s devices?
Among its 10 most recently registered devices, New Horizons Diagnostics Co. has devices listed in FDA 510(k) (10 devices).
What risk classes do New Horizons Diagnostics Co.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for New Horizons Diagnostics Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from New Horizons Diagnostics Co. in the registry?
The most recently registered devices listed for New Horizons Diagnostics Co. include NEISSERIA GONORRHOEAE TEST, RAPID BACTERIURIA SCREEN (RBS), SYPHILIS SEROLOGICAL REAGENTS and PYLORISCREEN.