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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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SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100750
In Commercial Distribution

  • 19555240400731 ()
  • 09555240400734 ()
A100750

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100740
In Commercial Distribution

  • 19555240400533 ()
  • 09555240400536 ()
A100740

  • Blood/blood culture specimen transfer spike IVD, manual
Device, Blood Mixing and Weighing
Fresenius Kabi AG
9029661
In Commercial Distribution

  • 04086000860765 ()
9029661

  • Blood donation rocker
Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029651
In Commercial Distribution

  • 04086000860758 ()
9029651

  • Blood donation rocker
Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029641
In Commercial Distribution

  • 04086000860741 ()
9029641

  • Blood donation rocker
The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.
Fresenius Kabi AG
9025571
In Commercial Distribution

  • 04086000860581 ()
9025571

  • Blood component separator, automated
The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems.
Fresenius Kabi AG
9025561
In Commercial Distribution

  • 04086000860475 ()
9025561

  • Blood component separator, automated
The CompoMat G5/ CompoMat G5 Plus/ CompoMaster Net G5 Plus system is intended to be used as an automatic blood component separator for blood component separation and processing.
Fresenius Kabi AG
9026561
In Commercial Distribution

  • 04086000860161 ()
9026561

  • Blood component separator, automated
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 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
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