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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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SOF-ROL STERILE 5CM X 3.6MTR 20
BSN MEDICAL, INC.
72345-10
In Commercial Distribution

  • 04042809667295 ()
  • 04042809438468 ()

  • Length: 360 Centimeter
  • Width: 5 Centimeter
72345-10

  • Cotton wool roll, sterile
NMR Reference Standard used for the Vantera Clinical Analyzer.
Labcorp of America
9930030
Not in Commercial Distribution

  • B3959930030 ()
9930030

  • Lipid profile analyser IVD, laboratory, automated
Sample Diluent 1 used for the Vantera Clinical Analyzer.
Labcorp of America
9920030
Not in Commercial Distribution

  • B3959920030 ()
9920030

  • Lipid profile analyser IVD, laboratory, automated
WASH Solution used for the Vantera Clinical Analyzer
Labcorp of America
9910030
Not in Commercial Distribution

  • B3959910030 ()
9910030

  • Lipid profile analyser IVD, laboratory, automated
Clinical Analyzer
Labcorp of America
9900300
Not in Commercial Distribution

  • B3959900300 ()
9900300

  • Lipid profile analyser IVD, laboratory, automated
Lipid and Glucose Measuring System
GERMAINE LABORATORIES, INC
ILM-0001A
In Commercial Distribution

  • 00695684773014 ()


  • Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence
  • Glucose IVD, kit, electrometry
  • Glucose IVD, control
  • Total cholesterol lipid IVD, kit, spectrophotometry
  • Total cholesterol lipid IVD, control
  • Triglyceride IVD, control
  • Triglyceride IVD, kit, spectrophotometry
Urispec + UA Reader w 4 Promo
HENRY SCHEIN, INC.
5700317
In Commercial Distribution

  • 00304040006580 ()
5700317

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine analyser IVD, laboratory, semi-automated
Urispec + UA Reader w 12 Promo
HENRY SCHEIN, INC.
9007507
In Commercial Distribution

  • 00304040001462 ()
9007507

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine analyser IVD, laboratory, semi-automated
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376322
In Commercial Distribution

  • 00630414571263 ()
10376322

  • Multichannel clinical chemistry analyser IVD, laboratory
Total Cholesterol Test System
FORA CARE INC.
Test N'GO Advance Voice
In Commercial Distribution

  • 00816042014482 ()


  • Glucose/ketone/lipid monitoring system IVD, home-use
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