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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Platelet PGDprime Positive and Negative Controls for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
PRM30C
In Commercial Distribution

  • 10850046056151 ()
PRM30C

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Reagents required to perform the Platelet PGDprime Test System. 20 test kit
Verax Biomedical Incorporated
PRM20R
In Commercial Distribution

  • 10850046056144 ()
PRM20R

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Test Reagents required for processing the sample prior to testing with the Platelet PGDprime Test Device. 100 test kit
Verax Biomedical Incorporated
PRM100R
In Commercial Distribution

  • 10850046056137 ()
PRM100R

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Test System required disposable sample pipettes, processing tubes and transfer pipettes. 100 test kit
Verax Biomedical Incorporated
PRM100D
In Commercial Distribution

  • 10850046056120 ()
PRM100D

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to run the Platelet PGDprime Test System.
Verax Biomedical Incorporated
PRM20T
In Commercial Distribution

  • 10850046056113 ()
PRM20T

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01463
In Commercial Distribution

  • 10850046056236 ()
  • 10850046056090 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01229
In Commercial Distribution

  • 10850046056243 ()
  • 10850046056083 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Processing Tubes are used to contain the platelet sample while processing with Reagents 1A, 1B and 2.
Verax Biomedical Incorporated
P01462
In Commercial Distribution

  • 10850046056236 ()
  • 10850046056076 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
Verax Biomedical Incorporated
P01230
In Commercial Distribution

  • 10850046056250 ()
  • 10850046056069 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Negative Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01113
In Commercial Distribution

  • 10850046056052 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
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