44 results · 65ms · Sources: EU EUDAMED, US FDA

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM ELECTROLYTE BUFFER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HICHEM AST REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HICHEM ISEKCI SOLUTION KIT 70010

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HICHEM ALP/AMP REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HICHEM ISE STANDARDS KIT 70011

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HI CHEM KINETIC CHOLESTEROL REAGENT #88218

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

URIC ACID REAGENT (PRODUCT #88219)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN

FDA 510(k)
FDA Class 1 ·Clinical Chemistry