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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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Creatinine enzymatic - ADVIA Chem. - RGT
Siemens Healthcare Diagnostics Inc.
11537235
In Commercial Distribution

  • 00630414306438 ()
  • 00630414610962 ()
11537235

  • Creatinine 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
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
DV/DM COV2G/CV2G POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417773
Not in Commercial Distribution

  • 00630414298405 ()
  • 00630414607054 ()
KC873

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
DV/DM COV2G/CV2G CAL
Siemens Healthcare Diagnostics Inc.
11417772
Not in Commercial Distribution

  • 00630414298399 ()
  • 00630414607047 ()
KC872

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL) Set - 2x2x2mL - 2PK
Siemens Healthcare Diagnostics Inc.
10997192
In Commercial Distribution

  • 00630414603407 ()
10997192

  • Sex hormone binding globulin (SHBG) IVD, calibrator
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