Diagnostic Systems Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 94
What Diagnostic Systems Laboratories, Inc. makes
Diagnostic Systems Laboratories, Inc. manufactures in vitro diagnostic (IVD) immunoassay kits for hormone and protein analysis, including radioimmunoassays (RIAs) and enzyme-linked immunosorbent assays (ELISAs). Products cover thyroid hormones (e.g., T3), parathyroid hormone (PTH), insulin, sex hormones (e.g., DHEA, androstenedione), and biomarkers like alpha-fetoprotein (AFP) and beta-2 microglobulin. Some assays are designed for intact hormone detection, while others measure crosslinked proteins or non-extracted biomarkers.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with many products authorised via the 510(k) pathway. These assays are intended for laboratory use in diagnosing or monitoring endocrine, metabolic, and oncological conditions. The manufacturer is based in the United States.
Catalogue
Search and filter all 94 devicesShowing 1-50 of 94
Frequently asked questions
How many devices does Diagnostic Systems Laboratories, Inc. have in the registry?
The registry currently lists 94 devices for Diagnostic Systems Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostic Systems Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Diagnostic Systems Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Diagnostic Systems Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Diagnostic Systems Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostic Systems Laboratories, Inc. in the registry?
The most recently registered devices listed for Diagnostic Systems Laboratories, Inc. include DSL ACTIVE SHBG (DSL 7400), ACTIVE T3 RIA, DSL BETA 2 MICROGLOBULIN (DSL 6200) and ACTIVE CROSSLAPS ELISA.