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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
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 ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution
- 10888234500667 ()
EGEL48
- Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution
- 10888234500650 ()
403594
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution
- 10888234500643 ()
404601
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution
- 10888234500636 ()
404600
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404598
Not in Commercial Distribution
- 10888234500629 ()
404598
- 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 Pak12 and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404589
Not in Commercial Distribution
- 10888234500582 ()
404589
- 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.
404579
Not in Commercial Distribution
- 10888234500568 ()
404579
- 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 PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404565
Not in Commercial Distribution
- 10888234500490 ()
404565
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution
- 10888234500476 ()
404560
- 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 and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution
- 10888234500407 ()
403622
- HLA class I antibody screening 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