Sangui Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Sangui Biotech, Inc. makes
Sangui Biotech, Inc. manufactures in vitro diagnostic (IVD) immunoassay kits for hormone and protein analysis, including ELISA-based tests for calcitonin, erythropoietin, parathyroid hormone (PTH), and adrenocorticotropic hormone (ACTH). The company also produces a carbohydrate-deficient transferrin (CDT) assay, used primarily for detecting alcohol use disorders. These products are designed for laboratory use to quantify specific biomarkers in patient samples.
The company’s diagnostic assays fall under FDA-regulated device classes, with most classified as Class I or Class II, requiring premarket notification (510(k)) submissions. These products are listed in the FDA’s 510(k) database, indicating their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
Sangui Biotech, Inc. Calcitonin Elisa Kit Ref K982491
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sangui Biotech, Inc. have in the registry?
The registry currently lists 5 devices for Sangui Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sangui Biotech, Inc.'s devices?
Among its 5 most recently registered devices, Sangui Biotech, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sangui Biotech, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sangui Biotech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sangui Biotech, Inc. in the registry?
The most recently registered devices listed for Sangui Biotech, Inc. include SANGUI BIOTECH, INC. CALCITONIN ELISA KIT, SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT, CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY and SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA.