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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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No Description
RANDOX LABORATORIES LIMITED
HN5067
In Commercial Distribution

  • 05055273208887 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
RANDOX LABORATORIES LIMITED
CG5022
In Commercial Distribution

  • 05055273207637 ()


  • Multiple coagulation factor IVD, control
This product is intended for in vitro diagnostic use, in the quality control of urine test strips.
RANDOX LABORATORIES LIMITED
UC5034
In Commercial Distribution

  • 05055273207590 ()


  • Multiple urine analyte IVD, control
This product is intended for in vitro use in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), Apolipoprotein A-1, Apolipoprotein B, Cholesterol and Triglyceride methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
LE2669
In Commercial Distribution

  • 05055273204193 ()


  • Multiple lipid analyte IVD, control
This product is intended for in vitro use in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), Apolipoprotein A-1, Apolipoprotein B, Cholesterol and Triglyceride methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
LE2662
In Commercial Distribution

  • 05055273204162 ()


  • Multiple lipid analyte IVD, control
The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 2 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 2 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
PTH10609
In Commercial Distribution

  • 05055273219821 ()
PTH10609

  • Parathyroid hormone (PTH) IVD, control
The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 2 (AMH10514) 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
AMH10514
In Commercial Distribution

  • 05055273217780 ()
AMH10514

  • Anti-Mullerian hormone (AMH) IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use in the quality control of Alpha-fetoprotein, Free Beta HCG, Free Estriol, Human Chorionic Gonadotrophin, Inhibin A and PAPP-A methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
MSS5025
In Commercial Distribution

  • 05055273217582 ()
MSS5025

  • Trisomy 21-risk hormone IVD, control
No Description
RANDOX LABORATORIES LIMITED
AO2801
In Commercial Distribution

  • 05055273213911 ()


  • Adiponectin IVD, control
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