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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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LIQUID CARDIAC CONTROL 1 - 05055273219043

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

LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) - 05055273210118

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

Liquid Immunoassay Control – Level 1 (IA CONTROL 1) - 05055273210101

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

FITC TdT Negative Control IgG2a - B7828200A03

Analyte Specific Reagent FITC conjugated mouse IgG2a negative control 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
8200A
In Commercial Distribution

  • B7828200A03 ()
8200

  • Terminal deoxynucleotidyl transferase (TdT) IVD, control

FITC TdT Negative Control IgG1 - B7828100A02

Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
8100A
In Commercial Distribution

  • B7828100A02 ()
8100

  • Terminal deoxynucleotidyl transferase (TdT) IVD, control

FITC TdT Reagent - B7826600D08

Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6600D
In Commercial Distribution

  • B7826600D08 ()
6600D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent

FITC TdT Reagent - B7826600C07

Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1)
Supertechs, Inc.
6600C
In Commercial Distribution

  • B7826600C07 ()
6600C

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent

FITC TdT Reagent - B7826600A05

Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1) 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
6600A
In Commercial Distribution

  • B7826600A05 ()
6600

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent

FITC TdT Reagent - B7826100D03

Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6100D
In Commercial Distribution

  • B7826100D03 ()
6100D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent

FITC TdT Reagent - B7826100C02

Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)
Supertechs, Inc.
6100C
In Commercial Distribution

  • B7826100C02 ()
6100C

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
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