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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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Immunofixation (IFE) Kit - 05051700011211

No Description
THE BINDING SITE GROUP LIMITED
XK001
Not in Commercial Distribution

  • 05051700011211 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Human IgM - ‘NL’ BINDARID™ Radial Immunodiffusion Kit - 05051700010467

No Description
THE BINDING SITE GROUP LIMITED
RN012.3
Not in Commercial Distribution

  • 05051700010467 ()


  • Total immunoglobulin M (IgM total) IVD, kit, precipitation/immunodiffusion

Human IgA - ‘NL’ BINDARID™ Radial Immunodiffusion Kit - 05051700010450

No Description
THE BINDING SITE GROUP LIMITED
RN010.3
Not in Commercial Distribution

  • 05051700010450 ()


  • Total immunoglobulin A (IgA total) IVD, kit, precipitation/immunodiffusion

Hydrashift 2 4 isatuximab - 03607360046425

No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent

HYDRASHIFT 2 4 daratumumab 20 tests - 03607360046395

No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent

Sample Diluent CAPI 3 IT (10) - 03607360026021

No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent

ANTISERA CAPI 3 IT (10) - 03607360026014

No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent

VersaPump Infuser - 00817708023404

The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
EMED TECHNOLOGIES CORPORATION
FP-0010209
In Commercial Distribution

  • 00817708023404 ()
FP-0010209

  • Ambulatory non-insulin infusion pump, mechanical, reusable

SCIg60 - 00817708023398

SCIg60 Infusion Pump Carrying Case
EMED TECHNOLOGIES CORPORATION
FP-0010032
In Commercial Distribution

  • 00817708023398 ()


  • Ambulatory non-insulin infusion pump, mechanical, reusable

SCIg60 Infusion System - 00817708020274

SCIg60 Infuser (Mechanical Pump) Assembly
EMED TECHNOLOGIES CORPORATION
FP-0010002
In Commercial Distribution

  • 00817708020274 ()
FP-0010002

  • Ambulatory non-insulin infusion pump, mechanical, reusable
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