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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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Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes - 10850046056120

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

Platelet PGDprime Test, 20 devices plus disposables - 10850046056113

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 - 10850046056090

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 - 10850046056083

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 - 10850046056076

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 - 10850046056069

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 - 10850046056052

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

Platelet PGDprime Positive Control - 10850046056045

Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01412
In Commercial Distribution

  • 10850046056045 ()


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

Platelet PGDprime Reagent 2 - 10850046056038

Platelet PGDprime Reagent 2 required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01214
In Commercial Distribution

  • 10850046056038 ()


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

Platelet PGDprime Reagent 1B - 10850046056021

Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01413
In Commercial Distribution

  • 10850046056021 ()


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