Adi Diagnostics, Inc.
CanadaFDA applicant, unverified
- Devices
- 4
What Adi Diagnostics, Inc. makes
Adi Diagnostics, Inc. manufactures rapid diagnostic tests for infectious disease detection, including reagents for syphilis antigen, chlamydia, Group A streptococcus, and a modified version of the Reagin test. These products are designed for point-of-care or laboratory use to identify bacterial infections.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are listed in the U.S. market under FDA oversight.
Catalogue
Visuwell(R) Reagin Test (Modification) Ref K900338
Regimes: 510(k) Registry: 510(k)Visuwell(R) Chlamydia Ref K900973
Regimes: 510(k) Registry: 510(k)Visuwell Group A Streptococcus Detection Kit Ref K890840
Regimes: 510(k) Registry: 510(k)Visuwell Syphilis Antigen Ref K910487
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Adi Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Adi Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Adi Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Adi Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Adi Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Adi Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Adi Diagnostics, Inc. in the registry?
The most recently registered devices listed for Adi Diagnostics, Inc. include VISUWELL(R) REAGIN TEST (MODIFICATION), VISUWELL(R) CHLAMYDIA, VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT and VISUWELL SYPHILIS ANTIGEN.