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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAL10565
In Commercial Distribution

  • 05055273219159 ()
LAL10565

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10618
In Commercial Distribution

  • 05055273219142 ()
CQ10618

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10617
In Commercial Distribution

  • 05055273219135 ()
CQ10617

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10616
In Commercial Distribution

  • 05055273219128 ()
CQ10616

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10536
In Commercial Distribution

  • 05055273219067 ()
CQ10536

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10535
In Commercial Distribution

  • 05055273219050 ()
CQ10535

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10534
In Commercial Distribution

  • 05055273219043 ()
CQ10534

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH Vitamin D,17-OH-Progesterone, Alpha-fetoprotein (AFP), Aldosterone, Androstenedione, Beta-2-Microglobulin (B-2M), CA125, CA15-3, CA19-9, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-Sulphate, Digoxin, Ferritin, Folate, FSH, Gentamicin, Growth Hormone (GH), Total Beta hCG, Homocysteine, IGF-1, Immunoglobulin E (IgE), Insulin, Luteinizing Hormone, NT-Pro BNP, Oestradiol, Paracetamol, Phenobarbital, Phenytoin, Progesterone, Prolactin, PSA Free, PSA Total, Sex Hormone Binding Globulin (SHBG), Anti TPO, T Uptake, Free T3, Total T3, Free T4 Total T4, Testosterone, Theophylline, Tobramycin, Thyroglobulin, Thyroid Stimulating Hormone (TSH), Troponin I, Troponin T, Valproic Acid, Vancomycin and Vitamin B12. The device is unassayed without target values and is suitable for use on both Immunoassay and Clinical Chemistry analysers. Liquid Immunoassay Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LIA5143
In Commercial Distribution

  • 05055273210118 ()
LIA5143

  • Multiple-type clinical chemistry analyte profile IVD, control
The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH Vitamin D,17-OH-Progesterone, Alpha-fetoprotein (AFP), Aldosterone, Androstenedione, Beta-2-Microglobulin (B-2M), CA125, CA15-3, CA19-9, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-Sulphate, Digoxin, Ferritin, Folate, FSH, Gentamicin, Growth Hormone (GH), Total Beta hCG, Homocysteine, IGF-1, Immunoglobulin E (IgE), Insulin, Luteinizing Hormone, NT-Pro BNP, Oestradiol, Paracetamol, Phenobarbital, Phenytoin, Progesterone, Prolactin, PSA Free, PSA Total, Sex Hormone Binding Globulin (SHBG), Anti TPO, T Uptake, Free T3, Total T3, Free T4 Total T4, Testosterone, Theophylline, Tobramycin, Thyroglobulin, Thyroid Stimulating Hormone (TSH), Troponin I, Troponin T, Valproic Acid, Vancomycin and Vitamin B12. The device is unassayed without target values and is suitable for use on both Immunoassay and Clinical Chemistry analysers. Liquid Immunoassay Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LIA5142
In Commercial Distribution

  • 05055273210101 ()
LIA5142

  • Multiple-type clinical chemistry analyte profile IVD, control
CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L
SPECTRUM MEDICAL LIMITED
SM.03.DTX
In Commercial Distribution

  • 05060434423757 ()
51-000089-00

  • Cardiopulmonary bypass system heating/cooling unit
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