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|• (FDA Code: KSZ / 864.9175)|
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
|• (FDA Code: KSR / 864.9100)|
An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
|• (FDA Code: KSS / 864.9050)|
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
|• (FDA Code: KSY / 864.9185)|
A blood grouping view box is a device with a glass or plastic viewing surface, which may be illuminated and heated, that is used to view cell reactions in antigen-antibody testing.
|• (FDA Code: KSO / 864.9275)|
A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
|• (FDA Code: LDT / 864.4010)|
|• (FDA Code: KSN / 864.9285)|
An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
|• (FDA Code: KSG / 864.9600)|
Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
|• (FDA Code: KSF / 864.9650)|
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
|• (FDA Code: KSK / 864.9400)|
A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.