Allelix, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Allelix, Inc. makes
Allelix, Inc. manufactures lateral flow immunoassay test kits for at-home use, including the Allelix Pregnancy Detection Kit (48-test format) and the Allelix Group A Streptococcus Detection Kit. These products are designed for rapid, point-of-care diagnostic testing of specific biomarkers in urine or swab samples.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. The kits are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Allelix Pregnancy Detection Kit 48 Test Kit Ref K871308
Regimes: 510(k) Registry: 510(k)Allelix Group A Streptococcus Detection Kit Ref K871620
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Allelix, Inc. have in the registry?
The registry currently lists 2 devices for Allelix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allelix, Inc.'s devices?
Among its 2 most recently registered devices, Allelix, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Allelix, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Allelix, 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, Inc. in the registry?
The most recently registered devices listed for Allelix, Inc. include ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT and ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT.