The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.

CliniMACS® Tubing Set (TS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.

CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.

CliniMACS® CD34 Reagent is a dark amber, non-viscous, colloidal solution containing an antibody conjugate in buffer. The conjugate consists of a murine IgG1 monoclonal antibody directed against the Class II epitope of the human CD34 antigen, which is chemically conjugated to dextran beads having an iron oxide/hydroxide core used in conjuction with the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.

CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.