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AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
Fresenius Kabi AG
X6R2301
In Commercial Distribution
- 14086000100950 ()
- 04086000100953 ()
X6R2301
- Apheresis system tubing set
Sterile Fluid Path.
Fresenius Kabi AG
X6R2350
In Commercial Distribution
- 04086000100175 ()
- 24086000100179 ()
- 14086000100172 ()
X6R2350
- Blood transfer set
For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2326
In Commercial Distribution
- 04086000100144 ()
- 14086000100141 ()
X6R2326
- Apheresis system tubing set
No Description
MILLIPORE (U.K.) LIMITED
6708858
In Commercial Distribution
- 04065266566086 ()
6708858
- Non-blood cell primer/calibrator/control material IVD, reagent
LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution
Fresenius Kabi AG
4C4300
4C4300
- Blood transfer set
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.
Miltenyi Biotec B.V. & Co. KG
73205
In Commercial Distribution
- 04049934004841 ()
162-01
- Magnetic cell separation system tubing set
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.
Miltenyi Biotec B.V. & Co. KG
73105
In Commercial Distribution
- 04049934004834 ()
161-01
- Magnetic cell separation system tubing set
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.
Miltenyi Biotec B.V. & Co. KG
70103
In Commercial Distribution
- 04049934004827 ()
171-01
- Magnetic cell separation system reagent
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.
Miltenyi Biotec B.V. & Co. KG
70026
In Commercial Distribution
- 04049934004674 ()
- 04049934001666 ()
700-25
- Magnetic cell separation system buffered saline solution
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.
Miltenyi Biotec B.V. & Co. KG
75101
In Commercial Distribution
- 04049934004636 ()
151-01
- Magnetic cell separation system processing unit
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.
Miltenyi Biotec B.V. & Co. KG
74404
In Commercial Distribution
- 04049934000317 ()
- 04049934001345 ()
200-074-404
- Blood/tissue storage/culture container
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.
Miltenyi Biotec B.V. & Co. KG
74403
In Commercial Distribution
- 04049934000300 ()
- 04049934001352 ()
200-074-403
- Blood/tissue storage/culture container
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.
Miltenyi Biotec B.V. & Co. KG
74402
In Commercial Distribution
- 04049934000294 ()
- 04049934001369 ()
200-074-402
- Blood/tissue storage/culture container
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.
Miltenyi Biotec B.V. & Co. KG
74401
In Commercial Distribution
- 04049934000287 ()
- 04049934001376 ()
200-074-401
- Blood/tissue storage/culture container
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.
Miltenyi Biotec B.V. & Co. KG
74400
In Commercial Distribution
- 04049934000270 ()
- 04049934001383 ()
200-074-400
- Blood/tissue storage/culture container
The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only.
NanoEnTek, Inc.
ADRC
In Commercial Distribution
- 08809317541143 ()
ADRC 020
- White blood cell count IVD, control
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.
NanoEnTek, Inc.
ADHK-050
In Commercial Distribution
- 08809317541006 ()
ADHK-050
- White blood cell count IVD, reagent
The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.
NanoEnTek, Inc.
ADAM-rWBC HT
In Commercial Distribution
- 08809317540993 ()
ADAM-rWBC HT
- White blood cell count IVD, kit, cell count
ADAMII-CD34 Kit provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII-CD34 Kit can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40.
NanoEnTek, Inc.
CD34K-050
In Commercial Distribution
- 08809317540634 ()
CD34K-050
- CD34 cell marker IVD, antibody
ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
NanoEnTek, Inc.
ADAMII
In Commercial Distribution
- 08809317540627 ()
- Haematological cell analyser IVD
ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in the human specimen.
NanoEnTek, Inc.
ADAM-rWBC2 System
In Commercial Distribution
- 08809317540504 ()
ADAM-rWBC2 System
- White blood cell count IVD, kit, cell count
ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
NanoEnTek, Inc.
ADAM-rWBC2
In Commercial Distribution
- 08809317540498 ()
ADAM-rWBC2
- White blood cell count IVD, kit, cell count
ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
NanoEnTek, Inc.
ADAM-rWBC
In Commercial Distribution
- 08809317540252 ()
ADAM-rWBC
- White blood cell count IVD, kit, cell count
LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution
- 10888234500841 ()
628220
- HLA class I & II antigen tissue typing IVD, kit, multiplex
For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution
- 10888234500827 ()
628515UDI
- Buffered sample diluent IVD
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution
- 10888234500810 ()
888627
- Laboratory instrument/analyser application software IVD
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
In Commercial Distribution
- 10888234500803 ()
888623
- Laboratory instrument/analyser application software IVD
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKAUTO-MAYO
Not in Commercial Distribution
- 10888234500728 ()
PAKAUTO-MAYO
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS100
Not in Commercial Distribution
- 10888234500674 ()
PAKPLUS100
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404590
Not in Commercial Distribution
- 10888234500599 ()
404590
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution
- 10888234500575 ()
404588
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution
- 10888234500551 ()
404578
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution
- 10888234500544 ()
404577
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution
- 10888234500537 ()
404576
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404574
Not in Commercial Distribution
- 10888234500520 ()
404574
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with LIFECODES B-Screen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403831
Not in Commercial Distribution
- 10888234500445 ()
403831
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Factor VIII Antibody Screen, PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403613
Not in Commercial Distribution
- 10888234500377 ()
403613
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, DonorScreen-HLA Class I and Class II, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403603
Not in Commercial Distribution
- 10888234500360 ()
403603
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution
- 10888234500261 ()
THROMBOTYPE1
- Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKAUTO
Not in Commercial Distribution
- 10888234500247 ()
PAKAUTO
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)