Product Classification / EMDN Category
FDA Product Code: KSS
Directory of devices assigned to product classification code KSS.
gudid
The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.
Manufacturer: Fresenius Kabi AG
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gudid
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.
Manufacturer: Fresenius Kabi AG
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gudid
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.
Manufacturer: Fresenius Kabi AG
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gudid
SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
SampLok Sampling Kit (SSK) - 20mL is used to transfers samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
SampLok Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
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.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
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.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
Capture LISS for Capture-R Ready Screen (10X) 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.
Manufacturer: IMMUCOR, INC.
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gudid
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.
Manufacturer: IMMUCOR, INC.
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gudid
Immucors Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
Manufacturer: IMMUCOR, INC.
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gudid
Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population.
Manufacturer: IMMUCOR, INC.
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gudid
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
Manufacturer: IMMUCOR, INC.
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gudid
The Capture-P Control set is composed of both negative and weak positive control material to control both the Capture-P and Capture-P Ready-Screen tests.
Manufacturer: IMMUCOR, INC.
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gudid
Capture-P Ready-Screen solid phase system is used to detect IgG HLA and platelet specific antibodies to platelets. This is a single microplate product.
Manufacturer: IMMUCOR, INC.
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gudid
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product.
Manufacturer: IMMUCOR, INC.
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gudid
Capture-P Indicator Red Cells are part of both the Capture-P and Capture-P Ready-Screen tests, and they are used to visualize the final reaction.
Manufacturer: IMMUCOR, INC.
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gudid
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 57 mL bottle version with six bottles packaged.
Manufacturer: IMMUCOR, INC.
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gudid
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 11.5 mL vial version with ten vials packaged.
Manufacturer: IMMUCOR, INC.
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gudid
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 11.5 mL vial version with one vial packaged.
Manufacturer: IMMUCOR, INC.
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gudid
Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
Manufacturer: IMMUCOR, INC.
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Autologous Platelet System - PRP X 2
Manufacturer: Musculoskeletal Transplant Foundation, Inc.
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The Ortho Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
Manufacturer: ITL ASIA PACIFIC SDN. BHD.
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gudid
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Manufacturer: Temptime Corporation
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gudid
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Manufacturer: Temptime Corporation
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MTS Worktable (plastic rack to hold cards and samples)
Manufacturer: MICRO TYPING SYSTEMS, INC
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