Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamp
Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers.
Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propox
Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers.
LAS
Drug Specific Control Materials
1
Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2
Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propox
Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers.
LAS
Drug Specific Control Materials
1
Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1
Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL
Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direct bilirubin in serum on the BS480 analyzers. For in vitro diagnostic use only.
Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-A
Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
DKB
Calibrators, Drug Mixture
2
Pointe Multi-Analyte Set C Urine DAU Low Calibrator
Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the qu
Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in serum. For in vitro diagnostic use.
These C-Reactive Protein Controls are intended for use in C-Reactive Protein (Hi
These C-Reactive Protein Controls are intended for use in C-Reactive Protein (High Sensitivity) Wide Range test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only.
DCK
C-Reactive Protein, Antigen, Antiserum, And Control
Intended for use as an BUN (Urea Nitrogen) standard for standardization or calib
Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures.
Iron Reagent is for the quantitative determination of iron (ferrozine) in serum
Iron Reagent is for the quantitative determination of iron (ferrozine) in serum on Hitachi analyzers. For in vitro diagnostic use only.6 x 66ml, 6 x 17ml
CK Reagent is for the quantitative determination of creatine kinase activity in
CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers.
Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl
Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl
Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination
Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use.4 x 20 ml., 2 x 10 ml.
JIT,DDZ
Calibrator, Secondary,Albumin, Fitc, Antigen, Antiserum, Control
Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x
Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x 17ml R2. For the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only.
Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x
Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.
Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x
Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10ml R2. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
CFJ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer,
Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer, 5x12mL Color Kit. For the quantitative determination of iron and total iron-binding capacity in serum. For in vitro diagnostic use only.
Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-q
Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.
Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative dete
Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. Packaged for use on Olympus Analyzers. 6 x 60ml, 6 x 20ml
Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determina
Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only.4 x 45ml
Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of ure
Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in serum on Olympus Analyzers. For in vitro diagnostic use only.6 x 66ml, 2 x 43ml
Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Asp
Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged with barcodes for use on AU400, AU480 and AU640.6 x 67ml, 5 x 17ml
Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative det
Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Packaged with barcodes for use on AU400, AU480 and AU640.5 x 50ml, 4 x 13ml.
Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determinati
Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.1 x 1L, 1 x 400ml
CFJ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
These Fructosamine Controls are intended for use in fructosamine test systems to
These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only.
Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone
Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
This product is for the purpose of standardizing results obtained from run to ru
This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml
Reagent for the quantitative determination of Glucose in serum. For in vitro di
Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 1000 ml
Reagent for the quantitative determination of Glucose in serum. For in vitro di
Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 500 ml
Reagent for the quantitative determination of Glucose in serum. For in vitro di
Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 120 ml
Reagent intended for use as an glucose standard for standardization or calibrati
Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures.1 x 100 mg/dl
Pointe Methadone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone
Pointe Methadone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
For the quantitative determination of alkaline phosphatase in human serum. For
For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Intended for use as an albumin standard for standardization or calibration of br
Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures.
Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodo
Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers.
LAS
Drug Specific Control Materials
1
Pointe Hydrocodone 100 Level 2 Control (125 ng/mL)
For the quantitative determination of total bilirubin in serum on Hitachi analyz
For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
For the quantitative determination of direct bilirubin in serum on Hitachi analy
For the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
For the quantitative determination of urea nitrogen in serum. For in vitro diag
For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates
Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates 2000 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Opiates 2000 Reagent Set (Ref# 60-OP0660-100/60-OP0660-1L) on a number of automated clinical chemistry analyzers.
LD Reagent is for the quantitative kinetic determination of lactate dehydrogenas
LD Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.5 x 42ml, 5 x 17ml.
CFJ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphe
Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers.
LAS
Drug Specific Control Materials
1
Pointe Methamphetamine Control (625 ng/mL) Level 2
Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Poin
Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 100 ng/mL on automated clinical chemistry analyzers.
DLJ
Calibrators, Drug Specific
2
Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High
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.