Allelix Diagnostics, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Allelix Diagnostics, Inc. makes
Allelix Diagnostics, Inc. manufactures diagnostic test kits, including the VISUWELL Reagin Test 960 Test Kit for syphilis antibody detection and the Modified Group A Streptococcus Detection Kit for rapid strep testing.
These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. The company’s devices are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Visuwell Reagin Test 960 Test Kit Ref K885298
Regimes: 510(k) Registry: 510(k)Modified Group A Streptococcus Detection Kit Ref K880665
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Allelix Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Allelix Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allelix Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Allelix Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Allelix Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Allelix 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 Allelix Diagnostics, Inc. in the registry?
The most recently registered devices listed for Allelix Diagnostics, Inc. include VISUWELL REAGIN TEST 960 TEST KIT and MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT.