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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. - 00811727013781

Reagent for the quantitative determination of Alanine Aminotransferase in serum. 1 x 30 ml
POINTE SCIENTIFIC, INC.
13-A7526-R2-30
In Commercial Distribution

  • 00811727013781 ()
13-A7526-R2-30

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

ALT R2 (w/ssa#) - 00811727013774

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R2-125
In Commercial Distribution

  • 00811727013774 ()
13-A7526-R2-125

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

ALT R1 (w/ssa#) - 00811727013767

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R1-500
In Commercial Distribution

  • 00811727013767 ()
13-A7526-R1-500

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

ALT R1 (w/ssa#) - 00811727013750

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R1-120
In Commercial Distribution

  • 00811727013750 ()
13-A7526-R1-120

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Creatinine Enzymatic - 00811727013507

For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only.
POINTE SCIENTIFIC, INC.
12-C7548-162
In Commercial Distribution

  • 00811727013507 ()
12-C7548-162

  • Creatinine IVD, kit, enzyme spectrophotometry

CK - 00811727013477

For the quantitative determination of creatine kinase activity in serum.
POINTE SCIENTIFIC, INC.
12-C7522-100
In Commercial Distribution

  • 00811727013477 ()
12-C7522-100

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

POINTE SCIENTIFIC BUN - 00811727013439

For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
12-B7552-150
In Commercial Distribution

  • 00811727013439 ()
12-B7552-150

  • Urea IVD, kit, enzyme spectrophotometry

POINTE SCIENTIFIC ALT - 00811727013408

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
12-A7526-100
In Commercial Distribution

  • 00811727013408 ()
12-A7526-100

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. CK - 00811727012999

CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers.
POINTE SCIENTIFIC, INC.
HC922-300
In Commercial Distribution

  • 00811727012999 ()
HC922-300

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

POINTE SCIENTIFIC CK (Liquid) - 00811727010933

For the quantitative determination of creatine kinase activity in serum.
POINTE SCIENTIFIC, INC.
C7522-625
In Commercial Distribution

  • 00811727010933 ()
C7522-625

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
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