Sqi Diagnostics Systems, Inc.
CanadaFDA applicant, unverified
- Devices
- 3
What Sqi Diagnostics Systems, Inc. makes
Sqi Diagnostics Systems, Inc. manufactures the IG_PLEX CELIAC DGP PANEL, a diagnostic test designed to detect celiac disease by measuring immunoglobulin G (IgG) antibodies against deamidated gliadin peptides (DGP). This device aids in the identification and monitoring of celiac disease through serological testing.
The IG_PLEX CELIAC DGP PANEL is classified as a Class II medical device and has been authorised through the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Igx Plex Celiac Qualitative Assay Ref K102490
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ig_plex Celiac Dgp Panel Ref K140691
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sqi Diagnostics Systems, Inc. have in the registry?
The registry currently lists 3 devices for Sqi Diagnostics Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sqi Diagnostics Systems, Inc.'s devices?
Among its 3 most recently registered devices, Sqi Diagnostics Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sqi Diagnostics Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sqi Diagnostics Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sqi Diagnostics Systems, Inc. in the registry?
The most recently registered devices listed for Sqi Diagnostics Systems, Inc. include IGX PLEX CELIAC QUALITATIVE ASSAY, IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM and IG_PLEX CELIAC DGP PANEL.