RANDOX OPIATES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Direct LDL Cholesterol (LDL)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RANDOX ALDOLASE CALIBRATION SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Total Bilirubin

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Triglycerides

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Direct Bilirubin

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Evidence MultiSTAT DOA Urine MultiPlex

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RANDOX TRI LEVEL CARDIAC CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

XANTHOCHROMIA CONTROL

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Randox Laboratories Limited·2 devices

URINE LOW OSMOLALITY CONTROL

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Randox Laboratories Limited·1 device

Liquid Immunoassay Control

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Randox Laboratories Limited·3 devices