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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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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
This product is intended for in vitro use, in the quality control of Alpha-fetoprotein, Free Beta hCG, Free Estriol, Human Chorionic Gonadotropin, Inhibin A and PAPP-A methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
MSS5024
In Commercial Distribution

  • 05055273217575 ()
MSS5024

  • Trisomy 21-risk hormone IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. 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
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
No Description
RANDOX LABORATORIES LIMITED
LE5018
In Commercial Distribution

  • 05055273209129 ()


  • Multiple apolipoprotein IVD, control
No Description
RANDOX LABORATORIES LIMITED
LE5017
In Commercial Distribution

  • 05055273209112 ()


  • Multiple apolipoprotein IVD, control
No Description
RANDOX LABORATORIES LIMITED
LE5016
In Commercial Distribution

  • 05055273209105 ()


  • Multiple apolipoprotein IVD, control
The Randox Benzodiazepines Control Level 2 is intended for use in the Quality Control of the Benzodiazepines (BENZ) assay. The Benzodiazepine Control Level 2 contains the specific drug Oxazepam.
RANDOX LABORATORIES LIMITED
DA3131
In Commercial Distribution

  • 05055273207996 ()
DA3131

  • Benzodiazepine group IVD, control
The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP.
RANDOX LABORATORIES LIMITED
DA3123
In Commercial Distribution

  • 05055273207910 ()
DA3123

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control
The Randox Multidrug Control Level 2 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays.
RANDOX LABORATORIES LIMITED
DA3122
In Commercial Distribution

  • 05055273207903 ()
DA3122

  • Multiple drugs of abuse IVD, control
The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4040
In Commercial Distribution

  • 05055273207774 ()
RX4040

  • Multiple clinical chemistry analyser IVD, laboratory
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