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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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AbsolutePRP 60mL GenesisCS Component Concentrating System - 00855306003008

No Description
EMCYTE CORP.
GS60
In Commercial Distribution

  • 00855306003008 ()
GS60

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration

BioHorizons - 00847236015978

Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system

Cascade - 00859070006043

Autologous Platelet System-PRFM x 2
Musculoskeletal Transplant Foundation, Inc.
910048
Not in Commercial Distribution

  • 00859070006043 ()
910048

  • Haematological concentrate system preparation kit, platelet concentration

Cascade - 00859070006029

Autologous Platelet System - PRP X 2
Musculoskeletal Transplant Foundation, Inc.
910047
Not in Commercial Distribution

  • 00859070006029 ()
910047

  • Haematological concentrate system preparation kit, platelet concentration

Cascade - 00859070006012

Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution

  • 00859070006012 ()
910044

  • Haematological concentrate system preparation kit, platelet concentration

Cascade - 00859070006005

Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution

  • 00859070006005 ()
910046

  • Haematological concentrate system preparation kit, platelet concentration

Cascade - 00859070006036

Autologous Platelet System - PRFM
Musculoskeletal Transplant Foundation, Inc.
910050
Not in Commercial Distribution

  • 00859070006036 ()
910050

  • Haematological concentrate system preparation kit, platelet concentration

Capture-P Indicator Red Cells - 10888234002314

Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives.
IMMUCOR, INC.
0066906
In Commercial Distribution

  • 10888234002314 ()
0066906

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

Capture LISS - 10888234002291

Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.
IMMUCOR, INC.
0066908
In Commercial Distribution

  • 10888234002291 ()
0066908

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Capture LISS - 10888234002147

Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the single 57 mL bottle version.
IMMUCOR, INC.
0006418
In Commercial Distribution

  • 10888234002147 ()
0006418

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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