Guardian Scientific, Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Guardian Scientific, Corp. makes
Guardian Scientific, Corp. manufactures rapid diagnostic test strips for detecting pregnancy, *E. coli* O157, and cholera in point-of-care settings. The QUIX series includes single-use lateral flow assays for quick, on-site results. The TRUST product line covers additional rapid diagnostic tests for infectious agents.
These devices are regulated under FDA’s 510(k) pathway, with classifications spanning Class I and Class II. They are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Quix Rapid Pregnancy Strip Test Ref K954993
Regimes: 510(k) Registry: 510(k)Quix Rapid E. Coli O157 Strip Test Ref K972156
Regimes: 510(k) Registry: 510(k)Trust Ref K954994
Regimes: 510(k) Registry: 510(k)Quix Rapid Cholera Strip Test Ref K954995
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Guardian Scientific, Corp. have in the registry?
The registry currently lists 4 devices for Guardian Scientific, Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guardian Scientific, Corp.'s devices?
Among its 4 most recently registered devices, Guardian Scientific, Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Guardian Scientific, Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Guardian Scientific, Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Guardian Scientific, Corp. in the registry?
The most recently registered devices listed for Guardian Scientific, Corp. include QUIX RAPID PREGNANCY STRIP TEST, QUIX RAPID E. COLI O157 STRIP TEST, TRUST and QUIX RAPID CHOLERA STRIP TEST.