Trace Scientific, Ltd.
Country not established
- Devices
- 55
What Trace Scientific, Ltd. makes
Trace Scientific, Ltd. manufactures diagnostic reagents for clinical chemistry testing, including enzymatic and colorimetric assays for liver function markers (ALT, AST), lipids (cholesterol), electrolytes (chloride, calcium, magnesium), bilirubin, protein, and uric acid. Their portfolio covers single-vial and multi-component reagents designed for laboratory use in measuring these analytes via automated or manual methods.
The company’s reagents are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) or Class II (special controls). Products are listed in the FDA’s 510(k) database and comply with applicable U.S. regulatory requirements for in vitro diagnostics.
Catalogue
Search and filter all 55 devicesShowing 1-50 of 55
Frequently asked questions
How many devices does Trace Scientific, Ltd. have in the registry?
The registry currently lists 55 devices for Trace Scientific, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trace Scientific, Ltd.'s devices?
Among its 50 most recently registered devices, Trace Scientific, Ltd. has devices listed in FDA 510(k) (50 devices).
What risk classes do Trace Scientific, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Trace Scientific, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trace Scientific, Ltd. in the registry?
The most recently registered devices listed for Trace Scientific, Ltd. include ALT INCORPORATING DST, IRON 5 X CONC REAGENT, TOTAL BILIRUBIN REAGENT - DMSO METHOD and ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT.