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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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Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B.
RANDOX LABORATORIES LIMITED
LV10357
In Commercial Distribution

  • 05055273216271 ()
LV10357

  • Multiple apolipoprotein IVD, control
Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides.
RANDOX LABORATORIES LIMITED
LV10344
In Commercial Distribution

  • 05055273216257 ()
LV10344

  • Multiple lipid analyte IVD, control
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAN4214
In Commercial Distribution

  • 05055273214536 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert.
RANDOX LABORATORIES LIMITED
LIA3108
In Commercial Distribution

  • 05055273207248 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
Curetis GmbH
M1 Master Mix Tube Kit
Not in Commercial Distribution

  • 04260364750041 ()
10020

  • DNA amplification enzyme reagent IVD
Optiflow Nasal Filtered Interface with CO2 Sampling Medium
FISHER & PAYKEL HEALTHCARE LIMITED
AA031JM
In Commercial Distribution

  • 09420012470959 ()
  • 09420012470942 ()

  • MEDIUM
AA031JM

  • Nasal oxygen cannula, basic
Adult Optiflow Heated Circuit Kit
FISHER & PAYKEL HEALTHCARE LIMITED
950A40J
In Commercial Distribution

  • 09420012461223 ()
  • 09420012461117 ()
950A40J

  • Ventilator breathing circuit, single-use
Calibra® Bio Capsule Sample
DENTSPLY INTERNATIONAL INC.
607608
In Commercial Distribution

  • D0026076080 ()
  • D0026076081 ()

  • 3 Capsules
607608

  • Dental composite resin
Calibra® Bio Evaluator Kit
DENTSPLY INTERNATIONAL INC.
607600
In Commercial Distribution

  • D0026076000 ()
  • D0026076001 ()

  • 5 Capsules, 1 Capsule Extruder
607600

  • Glass ionomer dental cement
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
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