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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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ALANINE AMINOTRANSFERASE (ALT) - 05055273200133

No Description
RANDOX LABORATORIES LIMITED
AL100
In Commercial Distribution

  • 05055273200133 ()
AL100

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

ALPHA-1-ACID-GLYCOPROTEIN (AGT) - 05055273200126

No Description
RANDOX LABORATORIES LIMITED
AG2472
Not in Commercial Distribution

  • 05055273200126 ()


  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3) - 05055273200119

No Description
RANDOX LABORATORIES LIMITED
AE1032
In Commercial Distribution

  • 05055273200119 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3) - 05055273200102

No Description
RANDOX LABORATORIES LIMITED
AD5002
In Commercial Distribution

  • 05055273200102 ()
AD5002

  • Aldolase IVD, control

ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2) - 05055273200096

No Description
RANDOX LABORATORIES LIMITED
AD5001
In Commercial Distribution

  • 05055273200096 ()
AD5001

  • Aldolase IVD, control

ALDOLASE (ALS) - 05055273200072

No Description
RANDOX LABORATORIES LIMITED
AD189
In Commercial Distribution

  • 05055273200072 ()


  • Aldolase IVD, kit, spectrophotometry

Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) - 05055273219203

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
LAE10627
In Commercial Distribution

  • 05055273219203 ()
LAE10627

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) - 05055273219197

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
LAN10626
In Commercial Distribution

  • 05055273219197 ()
LAN10626

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) - 05055273219180

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
LAL10625
In Commercial Distribution

  • 05055273219180 ()
LAL10625

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) - 05055273219173

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
LAE10567
In Commercial Distribution

  • 05055273219173 ()
LAE10567

  • Multiple-type clinical chemistry analyte profile IVD, control
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