Sigma Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 164
What Sigma Diagnostics, Inc. makes
Sigma Diagnostics, Inc. manufactures diagnostic reagent sets, calibrators, and controls for laboratory testing, including total thyroxine (T4), glucose, albumin, bile acids, liver enzymes (e.g., ALT, ALP), bilirubin, ethanol, valproic acid, reticulocyte stains, and iron/UIBC assays. Their products are designed for fluorescence polarization immunoassays (FPIA) and spectrophotometric procedures, supporting clinical chemistry and toxicology applications.
The company’s portfolio includes Class I and Class II devices under FDA regulation, with many products listed via the 510(k) pathway. These reagents and controls are intended for in vitro diagnostic use and are distributed globally, with the manufacturer headquartered in the United States.
Catalogue
Search and filter all 164 devicesShowing 1-50 of 164
Frequently asked questions
How many devices does Sigma Diagnostics, Inc. have in the registry?
The registry currently lists 164 devices for Sigma Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sigma Diagnostics, Inc.'s devices?
Among its 50 most recently registered devices, Sigma Diagnostics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Sigma Diagnostics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sigma 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 Sigma Diagnostics, Inc. in the registry?
The most recently registered devices listed for Sigma Diagnostics, Inc. include TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039, T-116, SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P, ALBUMIN (BCG) REAGENT and BILE ACIDS CALIBRATOR.