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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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Welch Allyn, Inc. - 00732094258738

Blue Max Supatab resting tab electrodes, wet gel, 33mm (1.30 in.). 100 electrodes/pack. Price per pack. Must order in increments of 24.
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094258738 ()
015-0630-00

  • Electrocardiographic electrode, single-use

Pointe Glucose Reagent - 00811727016157

Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For the in vitro quantitative measurement of glucose in serum.
POINTE SCIENTIFIC, INC.
16-G7517-528
In Commercial Distribution

  • 00811727016157 ()
16-G7517-528

  • Glucose IVD, kit, spectrophotometry

Pointe Scientific, Inc. Creatinine - 00811727014702

Creatinine Reagent, for the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Size: 1 x 2L, 1 x 500ml
POINTE SCIENTIFIC, INC.
HC739-2500
In Commercial Distribution

  • 00811727014702 ()
HC739-2500

  • Creatinine IVD, kit, spectrophotometry

Pointe Scientific, Inc. BUN - 00811727014658

BUN, for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Size: 1 x 2L, 1 x 500ml
POINTE SCIENTIFIC, INC.
HB752-2500
In Commercial Distribution

  • 00811727014658 ()
HB752-2500

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727014344

Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Size: 1 x 30 mL
POINTE SCIENTIFIC, INC.
13-L7572-R2-30
In Commercial Distribution

  • 00811727014344 ()
13-L7572-R2-30

  • Total lactate dehydrogenase (LDH) IVD, reagent

Pointe Scientific, Inc. - 00811727014337

Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Size: 1 x 125 mL
POINTE SCIENTIFIC, INC.
13-L7572-R2-125
In Commercial Distribution

  • 00811727014337 ()
13-L7572-R2-125

  • Total lactate dehydrogenase (LDH) IVD, reagent

Pointe Scientific, Inc. - 00811727014320

Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Size: 1 x 500 mL
POINTE SCIENTIFIC, INC.
13-L7572-R1-500
In Commercial Distribution

  • 00811727014320 ()
13-L7572-R1-500

  • Total lactate dehydrogenase (LDH) IVD, reagent

Pointe Scientific, Inc. - 00811727014313

Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Size: 1 x 120 mL
POINTE SCIENTIFIC, INC.
13-L7572-R1-120
In Commercial Distribution

  • 00811727014313 ()
13-L7572-R1-120

  • Total lactate dehydrogenase (LDH) IVD, reagent

CRP - 00811727013514

For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
12-C7568-40
In Commercial Distribution

  • 00811727013514 ()
12-C7568-40

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Pointe Scientific, Inc. - 00811727013187

U-TSH for the quantitative determination of the thyroid stimulating hormone (TSH) concentration in human serum. For in vitro diagnostic use only. 96 Tests.
POINTE SCIENTIFIC, INC.
T1003-96
In Commercial Distribution

  • 00811727013187 ()
T1003-96

  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
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