Reference Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 17
What Reference Diagnostics, Inc. makes
Reference Diagnostics, Inc. manufactures in vitro diagnostic reagents and kits for measuring serum ferritin, high-sensitivity C-reactive protein (hsCRP), lipid profiles (including LDL and HDL cholesterol), and iron-binding capacity (TIBC). Products include homogeneous assay reagents, magnetic bead-based tests, and calibrator sets for laboratory use in cardiovascular and metabolic health monitoring.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. Products are intended for professional laboratory use in the US and are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Reference Diagnostics, Inc. have in the registry?
The registry currently lists 17 devices for Reference Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reference Diagnostics, Inc.'s devices?
Among its 17 most recently registered devices, Reference Diagnostics, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Reference Diagnostics, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Reference 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 Reference Diagnostics, Inc. in the registry?
The most recently registered devices listed for Reference Diagnostics, Inc. include RDI HSFERRITIN KIT, RDI LIPIDIRECT MAGNETIC LDL REAGENT, RDI HOMOGENEOUS HDL CHOLESTEROL TEST and FERRITIN CALIBRATOR SET, CATALOG NO. 8203.