Seragen Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 20
What Seragen Diagnostics, Inc. makes
Seragen Diagnostics produces laboratory reagents and controls for clinical chemistry and hematology testing, including enzymatic glucose determination kits, iron-binding capacity accessories, and immunoassay controls for cardiac markers like CK/MB isoenzymes. Their portfolio also covers diagnostic tests for autoimmune markers (e.g., ENA/RNP, RF, DNA), urea nitrogen assays, and hematology quality controls for automated cell counters. Additional offerings include enzyme-linked immunoassay (ELISA) kits for hormones like ACTH and isoezyme controls for CK/LD.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I (general controls) and Class II (special controls). These reagents and controls are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Seragen Diagnostics, Inc. have in the registry?
The registry currently lists 20 devices for Seragen Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seragen Diagnostics, Inc.'s devices?
Among its 20 most recently registered devices, Seragen Diagnostics, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Seragen Diagnostics, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Seragen 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 Seragen Diagnostics, Inc. in the registry?
The most recently registered devices listed for Seragen Diagnostics, Inc. include TOTAL IRON-BINDING CAPACITY ACCESORY, CK/LD ISOENZYMES CONTROLS(HUMAN), SERATEST ENA(RNP/SM) DETERMINATION and ENZYMATIC GLUCOSE DETERMINATION.