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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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Triglycerides_2 (Trig_2) Atellica CH Assay 2000 Tests
Siemens Healthcare Diagnostics Inc.
11537222
In Commercial Distribution

  • 00630414305110 ()
  • 00630414610955 ()
11537222

  • Triglyceride IVD, kit, spectrophotometry
Enzymatic Creatinine_3 (ECre3) Atellica CH Assay 2000 Tests
Siemens Healthcare Diagnostics Inc.
11537216
In Commercial Distribution

  • 00630414301587 ()
  • 00630414610948 ()
11537216

  • Creatinine IVD, kit, spectrophotometry
Atellica CH C-Reactive Protein (RCRP) Reagent
Siemens Healthcare Diagnostics Inc.
11537223
In Commercial Distribution

  • 00630414305127 ()
  • 00630414610887 ()
11537223

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537241
In Commercial Distribution

  • 00630414305134 ()
  • 00630414610870 ()
11537241

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator
HDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537240
In Commercial Distribution

  • 00630414305165 ()
  • 00630414610863 ()
11537240

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
Antistreptolysin O (ASO_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537212
In Commercial Distribution

  • 00630414305097 ()
  • 00630414610856 ()
11537212

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Iron (Iron3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537211
In Commercial Distribution

  • 00630414305011 ()
  • 00630414610849 ()
11537211

  • Iron IVD, kit, spectrophotometry
HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests
Siemens Healthcare Diagnostics Inc.
11537213
In Commercial Distribution

  • 00630414305059 ()
  • 00630414610832 ()
11537213

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
Siemens Healthcare Diagnostics Inc.
11537817
In Commercial Distribution

  • 00630414609515 ()
11537817

  • Blood gas/haemoximetry analyser IVD, point-of-care
The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system.
Siemens Healthcare Diagnostics Inc.
11537761
In Commercial Distribution

  • 00630414607962 ()
11537761

  • Urine analyser IVD, point-of-care
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