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.
CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for
CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451
Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each
Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit.
Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g
Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas,
Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas,
Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas,
Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas,
Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celia
The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.
The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celi
The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.