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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 Scientific, Inc. - 00811727013903

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 30 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-30
In Commercial Distribution

  • 00811727013903 ()
13-B7552-R2-30

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013897

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 125 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-125
In Commercial Distribution

  • 00811727013897 ()
13-B7552-R2-125

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013880

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 500 ml
POINTE SCIENTIFIC, INC.
13-B7552-R1-500
In Commercial Distribution

  • 00811727013880 ()
13-B7552-R1-500

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013873

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 120 ml
POINTE SCIENTIFIC, INC.
13-B7552-R1-120
In Commercial Distribution

  • 00811727013873 ()
13-B7552-R1-120

  • Urea IVD, kit, enzyme spectrophotometry

Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN - 00843356101690

Bundle - IT0612, SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED INSTRUMENTS" tamper-proof label with adhesive backing - 100 Trays & 100 Labels
CYGNUS MEDICAL L.L.C.
IT0612-SI
In Commercial Distribution

  • 30843356101691 ()
  • 00843356101690 ()


  • Surgical instrument containment holder, single-use, non-sterile

ChloroChek® Chloridometer® Sweat Chloride Analyzer - 03661540304088

The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ELITECHGROUP INC.
Model 3400
In Commercial Distribution

  • 03661540304088 ()


  • Chloride coulometric titration analyser IVD, semi-automated

OPTICS ONE - 00815384020366

Zeiss Bonnet Cover 20 in Dia w/48mm Lens
MEDICAL TECHNIQUE, INC.
4705-40
In Commercial Distribution

  • 00815384020380 ()
  • 00815384020373 ()
  • 00815384020366 ()
4705-40

  • Instrument/equipment drape, single-use, sterile

OPTICS ONE - 00815384020397

Leica Bonnet Cover 20 in Dia w/68mm Lens
MEDICAL TECHNIQUE, INC.
4708-40
In Commercial Distribution

  • 00815384020410 ()
  • 00815384020403 ()
  • 00815384020397 ()
4708-40

  • Instrument/equipment drape, single-use, sterile

Direct Bilirubin Reagent Set - 00812137011893

For the quantitative determination of direct bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011893 ()
  • 00812137012258 ()
501-402

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry

Total Bilirubin Reagent Set - 00812137011909

For the quantitative determination of total bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011909 ()
  • 00812137012265 ()
501-403

  • Total bilirubin IVD, kit, enzyme spectrophotometry
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