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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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Atellica IM TNIH - 00630414006758

High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 500T
Siemens Healthcare Diagnostics Inc.
10997841
In Commercial Distribution

  • 00630414006758 ()
  • 00842768024559 ()
10997841

  • Troponin I IVD, kit, chemiluminescent immunoassay

Atellica IM TNIH - 00630414006703

High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10997840
In Commercial Distribution

  • 00630414006703 ()
10997840

  • Troponin I IVD, kit, chemiluminescent immunoassay

Dimension Vista System Flex reagent cartridge A1C KIT - 00630414006666

A1C Reagent Kit
Siemens Healthcare Diagnostics Inc.
10720885
In Commercial Distribution

  • 00630414006666 ()
K3105B

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Dimension Clinical Chemistry System A1C Kit - 00630414006659

A1C Reagent Kit
Siemens Healthcare Diagnostics Inc.
10720883
In Commercial Distribution

  • 00630414006659 ()
DF105B

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Atellica CH CK_L - 00630414006642

Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T
Siemens Healthcare Diagnostics Inc.
11097640
In Commercial Distribution

  • 00630414006642 ()
11097640

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

ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment - 00630414002880

ADVIA A1c_E Pretreatment Solution, 1L
Siemens Healthcare Diagnostics Inc.
10721048
In Commercial Distribution

  • 00630414002880 ()
10721048

  • Glycated haemoglobin (HbA1c) IVD, reagent

ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator - 00630414002873

ADVIA A1c_E Calibrator, 1x 3mL
Siemens Healthcare Diagnostics Inc.
10720859
In Commercial Distribution

  • 00630414002873 ()
10720859

  • Glycated haemoglobin (HbA1c) IVD, calibrator

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002866

ADVIA A1c_E Reagent (Large Kit), 1200 tests
Siemens Healthcare Diagnostics Inc.
10720858
In Commercial Distribution

  • 00630414002866 ()
10720858

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002859

ADVIA A1c_E Reagent (Small Kit), 300 tests
Siemens Healthcare Diagnostics Inc.
10720857
In Commercial Distribution

  • 00630414002859 ()
10720857

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

Atellica CH MULTIDRUG QC - 00630414002699

Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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