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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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Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-AM0200-100
In Commercial Distribution

  • 00811727016539 ()
60-AM0200-100

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
16-HU982-308
In Commercial Distribution

  • 00811727016294 ()
16-HU982-308

  • Uric acid IVD, reagent
Pointe Uric Acid Reagent packaged for use on the Mindray BS480. 4 x 40ml. For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
14-U7581-160
In Commercial Distribution

  • 00811727015990 ()
14-U7581-160

  • Uric acid IVD, reagent
Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 9 x 65ml, 8 x 16ml
POINTE SCIENTIFIC, INC.
OU982-713
In Commercial Distribution

  • 00811727015136 ()
OU982-713

  • Uric acid IVD, reagent
Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. 1 x 1L, 1 x 250ml
POINTE SCIENTIFIC, INC.
HU982-1250
In Commercial Distribution

  • 00811727014849 ()
HU982-1250

  • Uric acid IVD, reagent
Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 500 mL
POINTE SCIENTIFIC, INC.
13-U7581-500
In Commercial Distribution

  • 00811727014467 ()
13-U7581-500

  • Uric acid IVD, reagent
Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 120 mL
POINTE SCIENTIFIC, INC.
13-U7581-120
In Commercial Distribution

  • 00811727014450 ()
13-U7581-120

  • Uric acid IVD, reagent
KIT, WELCOME ADMISSION B
Cardinal Health 200, LLC
AMN4226771
In Commercial Distribution

  • 50198956063882 ()
  • 10198956063884 ()
AMN4226771

  • General surgical procedure kit, non-medicated, single-use
Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac Science(TM) electrodes part number 9131-001
AED BRANDS, LLC
AB 9131-001
In Commercial Distribution

  • 90865292000106 ()
  • 90865292000113 ()


  • Electrode conductive skin pad, single-use
ME-060-03-100 Nafion Dryer
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 90840106905259 ()
  • 90840106905235 ()
  • 90840106905266 ()
ME-060-03-100

  • Gas-sampling/monitoring respiratory tubing, single-use
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