Helix Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Helix Diagnostics, Inc. makes
Helix Diagnostics, Inc. manufactures enzyme immunoassay test kits for detecting various antibodies associated with autoimmune conditions, including anti-double stranded DNA, anti-SCI-70, anti-SS-B/LA, anti-SS-A/RO, anti-SM, anti-JO-1, anti-ssDNA, and lupus screening tests, as well as the Diamedix Immunosimplicity ANA screen test system and ENA plus screening test kit.
The company's products are Class II medical devices listed in the FDA 510(k) registry, and Helix Diagnostics, Inc. is based in the US.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Helix Diagnostics, Inc. have in the registry?
The registry currently lists 15 devices for Helix Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helix Diagnostics, Inc.'s devices?
Among its 15 most recently registered devices, Helix Diagnostics, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Helix Diagnostics, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Helix Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Helix Diagnostics, Inc. in the registry?
The most recently registered devices listed for Helix Diagnostics, Inc. include ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT, ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT, DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM and ANTI-SS-B/LA ANTIBODY TEST.