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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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Plasma Control Tri-Level - 04250317522498

Plasma Control Tri-Level, Itraconazole, Posaconazole, Voriconazole in serum/plasma
Chromsystems Instruments + Chemicals GmbH
0330
In Commercial Distribution

  • 04250317522498 ()

  • 3 x 5 x 1ml
0330

  • Multiple antifungal therapeutic drug monitoring IVD, control

Plasma Calibrator Set - 04250317522450

3PLUS1® Multilevel Plasma Calibrator Set Itraconazole, Posaconazole, Voriconazole
Chromsystems Instruments + Chemicals GmbH
27029
In Commercial Distribution

  • 04250317522450 ()

  • 4 Vials
  • Total Volume: 1 Milliliter
27029

  • Multiple antifungal therapeutic drug monitoring IVD, calibrator

Serum Control Bi-Level - 04250317522238

Serum Control Level I, II Rufinamide, Felbamate, Lacosamide in serum/plasma
Chromsystems Instruments + Chemicals GmbH
0065
In Commercial Distribution

  • 04250317522238 ()

  • 2 x 5 x 2ml
0065

  • Multiple anticonvulsant therapeutic drug monitoring IVD, control

Whole Blood Calibrator Set - 04250317521637

6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants
Chromsystems Instruments + Chemicals GmbH
28039/XL
In Commercial Distribution

  • 04250317521637 ()

  • Total Volume: 2 Milliliter
  • 7 Vials
28039/XL

  • Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

HPLC Column - 04250317521118

HPLC Column, High Resolution Levetiracetam (Keppra®) in serum/plasma
Chromsystems Instruments + Chemicals GmbH
24100/HR
In Commercial Distribution

  • 04250317521118 ()

  • 1 pcs.
24100/HR

  • High performance liquid chromatography analyser column IVD

Plasma Calibrator Set - 04250317520777

3PLUS1® Multilevel Plasma Calibrator Set Imatinib, Dasatinib, Nilotinib
Chromsystems Instruments + Chemicals GmbH
58028
In Commercial Distribution

  • 04250317520777 ()

  • Total Volume: 2 Milliliter
  • 4 Vials
58028

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

Plasma Control Bi-Level - 04250317520708

Plasma Control Bi-Level, Imatinib, Dasatinib, Nilotinib
Chromsystems Instruments + Chemicals GmbH
0224
In Commercial Distribution

  • 04250317520708 ()

  • 2 x 5 x 2ml
0224

  • Multiple-therapy therapeutic drug monitoring IVD, control

HPLC Column - 04250317520364

HPLC Column, Vitamin B2 in whole blood
Chromsystems Instruments + Chemicals GmbH
37110
In Commercial Distribution

  • 04250317520364 ()

  • 1 pcs.
37110

  • High performance liquid chromatography analyser column IVD

Trap Column - 04250317520210

Trap Column, MassTox Immunosuppressants in whole blood
Chromsystems Instruments + Chemicals GmbH
93110
In Commercial Distribution

  • 04250317520210 ()

  • 1 pcs.
93110

  • High performance liquid chromatography analyser column IVD

Analytical Column - 04250317520203

Analytical Column, MassTox® Immunosuppressants in whole blood
Chromsystems Instruments + Chemicals GmbH
93100
In Commercial Distribution

  • 04250317520203 ()

  • 1 pcs.
93100

  • High performance liquid chromatography analyser column IVD
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