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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

Phoenix Diagnostics - 00852676007070

LiquiCV EZ Enzyme Linearity Control
PHOENIX DIAGNOSTICS, INC.
PH5009
In Commercial Distribution

  • 00852676007070 ()
  • 10852676007077 ()

  • Total Volume: 5 Milliliter
PH5009

  • Multiple clinical chemistry enzyme IVD, control

INSTI Test Controls HIV-1 - 06865978010710

INSTI Test Controls HIV-1
Biolytical Laboratories Inc
80-1071
Not in Commercial Distribution

  • 06865978010710 ()
80-1071

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical

INSTI HIV-1/HIV-2 Test Controls - 06865978010376

INSTI HIV-1/HIV-2 Test Controls
Biolytical Laboratories Inc
80-1037
Not in Commercial Distribution

  • 06865978010376 ()
80-1037

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical

ARCHITECT - 00380740002114

ARCHITECT Folate Controls
ABBOTT IRELAND
1P74-12
In Commercial Distribution

  • 00380740002114 ()
01P7412

  • Folate (vitamin B9) IVD, control

ARCHITECT - 00380740014896

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

  • 00380740014896 ()
07K7710

  • Progesterone IVD, control

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

Alinity - 00380740136536

Alinity i Folate Calibrators
ABBOTT IRELAND
08P1402
In Commercial Distribution

  • 00380740136536 ()
08P1402

  • Folate (vitamin B9) IVD, calibrator
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