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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 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
LP5047
In Commercial Distribution

  • 05055273209204 ()


  • Multiple apolipoprotein IVD, calibrator
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 AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS8306
In Commercial Distribution

  • 05055273208245 ()
AS8306

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent
No Description
RANDOX LABORATORIES LIMITED
AP8302
In Commercial Distribution

  • 05055273208207 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry
The EDDP assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine.
RANDOX LABORATORIES LIMITED
DA4013
In Commercial Distribution

  • 05055273208061 ()
DA4013

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent
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 Benzodiazepines Calibrator Set is intended for use in the calibration of the Benzodiazepines assay. The Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam.
RANDOX LABORATORIES LIMITED
DA3129
In Commercial Distribution

  • 05055273207972 ()
DA3129

  • Benzodiazepine group IVD, calibrator
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 Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays.
RANDOX LABORATORIES LIMITED
DA2704
In Commercial Distribution

  • 05055273207880 ()
DA2704

  • Multiple drugs of abuse IVD, calibrator
The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay.
RANDOX LABORATORIES LIMITED
DA2702
In Commercial Distribution

  • 05055273207866 ()
DA2702

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
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
No Description
RANDOX LABORATORIES LIMITED
CG5023
In Commercial Distribution

  • 05055273207644 ()


  • Multiple coagulation factor IVD, control
No Description
RANDOX LABORATORIES LIMITED
CG5022
In Commercial Distribution

  • 05055273207637 ()


  • Multiple coagulation factor IVD, control
HORMONE PELLET TRAY
Cardinal Health 200, LLC
09-7774A
In Commercial Distribution

  • 50888439957325 ()
  • 10888439957327 ()
09-7774A

  • General surgical procedure kit, medicated
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
4919-000
In Commercial Distribution

  • 00848665035667 ()


  • Orthopaedic fixation implant alignment tool
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