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.
The calcium test system is a device intended for the quantitative in vitro deter
The calcium test system is a device intended for the quantitative in vitro determination of calcium concentration in serum, plasma or urine
The calcium test system is a device intended for the quantitative in vitro deter
The calcium test system is a device intended for the quantitative in vitro determination of calcium concentration in serum, plasma or urine
The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in
The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an
The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer
The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist
The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz
The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz
The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.