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 Cocaine assay is an in vitro diagnostic test for the qualitative and semi-qu
The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine.
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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.
Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ME
Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
The xReader System consists of a small, portable high resolution flatbed scanner
The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff 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 xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.