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 devicesLD1 Isoenzyme Reagent Kit Ref K890996
Regimes: 510(k) Registry: 510(k)Urea Ref K981123
Regimes: 510(k) Registry: 510(k)Enzymatic Glucose Reagent (Hexokinase) Ref K860724
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Showing 51-55 of 55