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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 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

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

Atellica Sample Handler Additional - 00630414002460

Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD

Atellica Sample Handler Prime - 00630414002439

Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD

Atellica Direct Load Kit - 00630414002354

Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD

Atellica Direct Load - 00630414002347

Atellica DL MODULE
Siemens Healthcare Diagnostics Inc.
11068008
In Commercial Distribution

  • 00630414002347 ()
11068008

  • Specimen processing instrument IVD

Atellica CH 930 Analyzer - 00630414002163

Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics Inc.
11067000
In Commercial Distribution

  • 00630414002163 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory

Atellica IM 1600 Analyzer - 00630414002026

Atellica IM 1600 Analyzer
Siemens Healthcare Diagnostics Inc.
11066000
In Commercial Distribution

  • 00630414002026 ()
11066000

  • Chemiluminescent immunoassay analyser IVD

Xprecia Stride™ Accessory Kit - 00630414001975

Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software

ADVIA Chemistry CO2_c - 00630414000541

ADVIA Chemistry CO2_c 20mL
Siemens Healthcare Diagnostics Inc.
10720780
In Commercial Distribution

  • 00630414000541 ()
  • 00630414300122 ()
10720780

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry

VERSANT - 00630414000534

LiPAScan software
Siemens Healthcare Diagnostics Inc.
10492006
In Commercial Distribution

  • 00630414000534 ()
10492006

  • Laboratory instrument/analyser application software IVD
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