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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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BLOOD GAS CONTROL - LEVEL 1 (BG CONTROL 1) - 05055273227109

No Description
RANDOX LABORATORIES LIMITED
BG5001
In Commercial Distribution

  • 05055273227109 ()
BG5001

  • Multiple blood gas analyte IVD, control

CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) - 05055273217650

This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control

MATERNAL CONTROL - LEVEL 3 (MATERNAL CONTROL 3) - 05055273217599

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
MSS5026
In Commercial Distribution

  • 05055273217599 ()
MSS5026

  • Trisomy 21-risk hormone IVD, control

MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2) - 05055273217582

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

MATERNAL CONTROL - LEVEL 1 (MATERNAL CONTROL 1) - 05055273217575

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

CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) - 05055273217346

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

APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) - 05055273209204

No Description
RANDOX LABORATORIES LIMITED
LP5047
In Commercial Distribution

  • 05055273209204 ()


  • Multiple apolipoprotein IVD, calibrator

APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) - 05055273209129

No Description
RANDOX LABORATORIES LIMITED
LE5018
In Commercial Distribution

  • 05055273209129 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2) - 05055273209112

No Description
RANDOX LABORATORIES LIMITED
LE5017
In Commercial Distribution

  • 05055273209112 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) - 05055273209105

No Description
RANDOX LABORATORIES LIMITED
LE5016
In Commercial Distribution

  • 05055273209105 ()


  • Multiple apolipoprotein IVD, control
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