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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MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level I
Chromsystems Instruments + Chemicals GmbH
0192
In Commercial Distribution

  • 04250317502841 ()

  • 1 x 3spots
0192

  • Newborn metabolic screen/congenital disorder IVD, control
MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Bi-Level
Chromsystems Instruments + Chemicals GmbH
0191
In Commercial Distribution

  • 04250317502834 ()

  • 2 x 3 spots
0191

  • Newborn metabolic screen/congenital disorder IVD, control
Precolum Cartridge 4/10, Benzodiazepines, Tricyclic Antidepressants in serum/plasma
Chromsystems Instruments + Chemicals GmbH
17049
In Commercial Distribution

  • 04250317502537 ()

  • 1 pcs.
17049

  • High performance liquid chromatography analyser column IVD
Precolum Cartridge 4/10, Mycophenolic Acid in plasma/serum
Chromsystems Instruments + Chemicals GmbH
17046
In Commercial Distribution

  • 04250317502506 ()

  • 1 pcs.
17046

  • High performance liquid chromatography analyser column IVD
Precolum Cartridge 4/10, Vitamin B2 in whole blood
Chromsystems Instruments + Chemicals GmbH
17037
In Commercial Distribution

  • 04250317502452 ()
17037

  • High performance liquid chromatography analyser column IVD
Urine Control Bi-Level, t,t-Muconic acid in urine
Chromsystems Instruments + Chemicals GmbH
0161
In Commercial Distribution

  • 04250317502148 ()

  • 2 x 5 x 2ml
0161

  • Organic solvent metabolite IVD, control
HPLC Column, ß-Thalassemia Screening
Chromsystems Instruments + Chemicals GmbH
15490
In Commercial Distribution

  • 04250317502018 ()

  • 1 pcs.
15490

  • High performance liquid chromatography analyser column IVD
HPLC Column, Hemoglobin Variants
Chromsystems Instruments + Chemicals GmbH
15390
In Commercial Distribution

  • 04250317501813 ()

  • 1 pcs.
15390

  • High performance liquid chromatography analyser column IVD
Plasma Control Bi-Level, Olanzapine, Desmethylolanzapine
Chromsystems Instruments + Chemicals GmbH
0147
In Commercial Distribution

  • 04250317501325 ()

  • 2 x 5 x 5ml
0147

  • Multiple antipsychotic therapeutic drug monitoring IVD, control
Urine Control Bi-Level, Porphyrins in urine
Chromsystems Instruments + Chemicals GmbH
0144
In Commercial Distribution

  • 04250317501271 ()

  • 2 x 5 x 2ml
0144

  • Total porphyrin (coproporphyrin/uroporphyrin) IVD, control
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