The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic
The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
This product is intended for in vitro use, in the quality control of Cardiac Mar
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
This is required for measuring reference electrode potential of an ion selective
This is required for measuring reference electrode potential of an ion selective electrode module.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
The Reagent Precision Test is used on the RX series clinical chemistry systems f
The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho
Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma.
This product should be used in conjunction with RX daytona plus reagents to dilu
This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
The is intended for the quantitative in vitro diagnostic determination of Creati
The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine
Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cho
Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma.
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Cont
The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid.
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
This product is intended for in vitro diagnostic use, in the quality control of
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. Thismaterial can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
JJY
Multi-Analyte Controls, All Kinds (Assayed)
1
IMMUNOASSAY SPECIALITY II - LEVEL 2 (IA SPECIALITY II LEV 2)
The Randox Multidrug Calibrator Set is intended for use in the calibration of Me
The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays.
DKB,DLJ
Calibrators, Drug Mixture,Calibrators, Drug Specific
The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e
The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay.
The Randox RX daytona plus without ISE is a fully automated, random access, clin
The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
The Randox RX daytona plus with ISE is a fully automated, random access, clinica
The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
This product is intended for in vitro diagnostic use, as assayed quality control
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.
JJY
Multi-Analyte Controls, All Kinds (Assayed)
1
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed
The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays statedin this package insert.
JJY
Multi-Analyte Controls, All Kinds (Assayed)
1
LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3)
This product should be used in conjunction with RX series reagents to dilute sam
This product should be used in conjunction with RX series reagents to dilute samples prior to assay
The Reagent Precision Test is used on the RX series clinical chemistry systems f
The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
Liquid Protein Calibrators are an in vitro diagnostic product used for the calib
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution.
Liquid Protein Calibrators are an in vitro diagnostic product used for the calib
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays.
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target valu
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
JJY
Multi-Analyte Controls, All Kinds (Assayed)
1
HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the
The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays.
Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and
Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser.
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
The eScreen eCup® is a patented urine collection device designed to allow for ra
The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCup is placed into the eReader device, its test strips are digitally screened for the presence or absence of drugs of abuse.
The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is int
The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations:Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL.Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
A rapid, one step screening test for the simultaneous, qualitative detection of
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.