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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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ADVIA Chemistry P5PL_c Reagent - 00630414008950

ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc
Siemens Healthcare Diagnostics Inc.
10729782
In Commercial Distribution

  • 00630414306193 ()
  • 00630414008950 ()
10729782

  • Multiple clinical chemistry enzyme IVD, reagent

ADVIA Chemistry Creatine Kinase - 00630414008943

4 wedges per reagent , 2 reagent, 1100 test per carton
Siemens Healthcare Diagnostics Inc.
10729780
In Commercial Distribution

  • 00630414008943 ()
10729780

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

Atellica IM 1300 Analyzer - 00630414007960

Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD

Atellica CH Li - 00630414006789

Lithium (Lith) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097535
Not in Commercial Distribution

  • 00630414006789 ()
11097535

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

Atellica IM TNIH MCM - 00630414006772

High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml
Siemens Healthcare Diagnostics Inc.
10997842
In Commercial Distribution

  • 00630414006772 ()
10997842

  • Troponin I IVD, control

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

IMMULITE 2000 rPru av 3 Specific Allergen - 00630414006253

rPru av 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471074
In Commercial Distribution

  • 00630414006253 ()
A599L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

BN II System - 00630414002903

The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
11254820
In Commercial Distribution

  • 00630414002903 ()
OVIA112

  • Nephelometry immunoassay analyser IVD

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
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