Dade Chemistry Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 13
What Dade Chemistry Systems, Inc. makes
Dade Chemistry Systems, Inc. manufactures calibrators, controls, and reagent cartridges for clinical chemistry testing, including prostate-specific antigen (PSA), human chorionic gonadotropin (hCG), thyroid-stimulating hormone (TSH), troponin, ferritin, and free thyroxine (FT4) assays. Their products are designed for use with automated clinical chemistry systems, ensuring accurate measurement of biomarkers and hormones in patient samples. The portfolio also includes methods for specific assays, such as the MMB (myocardial band) test, which aids in cardiac marker analysis.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as either Class I or Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Dade Chemistry Systems, Inc. have in the registry?
The registry currently lists 13 devices for Dade Chemistry Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dade Chemistry Systems, Inc.'s devices?
Among its 13 most recently registered devices, Dade Chemistry Systems, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Dade Chemistry Systems, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Dade Chemistry Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dade Chemistry Systems, Inc. in the registry?
The most recently registered devices listed for Dade Chemistry Systems, Inc. include PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR, HUMAN CHORIONIC GONADOTROPIN CALIBRATOR, THYROID STIMULATING HORMONE METHOD and TROPONIN (TROP) METHOD.