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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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No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent
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 Infusion Pump Carrying Case
EMED TECHNOLOGIES CORPORATION
FP-0010032
In Commercial Distribution

  • 00817708023398 ()


  • Ambulatory non-insulin infusion pump, mechanical, reusable
SCIg60 Infuser (Mechanical Pump) Assembly
EMED TECHNOLOGIES CORPORATION
FP-0010002
In Commercial Distribution

  • 00817708020274 ()
FP-0010002

  • Ambulatory non-insulin infusion pump, mechanical, reusable
IgM (Immunoglobulin M) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC638
Not in Commercial Distribution

  • 00817302020953 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC638

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-015
In Commercial Distribution

  • 00816426020115 ()
KAI-015

  • Total immunoglobulin M (IgM total) IVD, reagent
For the quantitative determination of human IgA in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-013
In Commercial Distribution

  • 00816426020092 ()
KAI-013

  • Total immunoglobulin A (IgA total) IVD, reagent
No Description
THE BINDING SITE GROUP LIMITED
XK003
Not in Commercial Distribution

  • 05051700011235 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
XK001
Not in Commercial Distribution

  • 05051700011211 ()


  • Protein electrophoresis IVD, kit, electrophoresis
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