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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 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

Alinity - 00380740194048

Alinity i STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
04Z2101
In Commercial Distribution

  • 00380740194048 ()
04Z2101

  • Troponin I IVD, calibrator

Alinity - 00380740136536

Alinity i Folate Calibrators
ABBOTT IRELAND
08P1402
In Commercial Distribution

  • 00380740136536 ()
08P1402

  • Folate (vitamin B9) IVD, calibrator

ARCHITECT - 00380740112776

ARCHITECT Intact PTH Controls
Abbott GmbH
8K25-12
Not in Commercial Distribution

  • 00380740112776 ()
08K2512

  • Parathyroid hormone (PTH) IVD, control

ARCHITECT - 00380740112769

ARCHITECT Intact PTH Calibrators
Abbott GmbH
8K25-03
Not in Commercial Distribution

  • 00380740112769 ()
08K2503

  • Parathyroid hormone (PTH) IVD, calibrator

ARCHITECT - 00380740014896

ARCHITECT Progesterone Controls
ABBOTT IRELAND
7K77-10
In Commercial Distribution

  • 00380740014896 ()
07K7710

  • Progesterone IVD, control

ARCHITECT - 00380740014889

ARCHITECT Progesterone Calibrators
ABBOTT IRELAND
7K77-01
In Commercial Distribution

  • 00380740014889 ()
07K7701

  • Progesterone IVD, calibrator

ARCHITECT - 00380740014841

ARCHITECT Prolactin Controls
ABBOTT IRELAND
7K76-10
In Commercial Distribution

  • 00380740014841 ()
07K7610

  • Prolactin IVD, control

ARCHITECT - 00380740014834

ARCHITECT Prolactin Calibrators
ABBOTT IRELAND
7K76-01
In Commercial Distribution

  • 00380740014834 ()
07K7601

  • Prolactin IVD, calibrator

ARCHITECT - 00380740007812

ARCHITECT HbA1c Calibrators
Abbott GmbH
4P72-01
Not in Commercial Distribution

  • 00380740007812 ()
04P7201

  • Glycated haemoglobin (HbA1c) IVD, calibrator
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