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Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1 Positive Control
In Commercial Distribution
- 00850032683012 ()
- HIV1 nucleic acid IVD, control
Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1/HCV/HBV Negative Control
In Commercial Distribution
- 00850032683005 ()
- PCR/NAT negative control IVD
PK7400 Automated Microplate System
Beckman Coulter, Inc.
B53299
In Commercial Distribution
- 14987666543344 ()
- Blood group/antibody screening analyser IVD
PK7300
Beckman Coulter, Inc.
N3209000
In Commercial Distribution
- 14987666535721 ()
N3209000
- Blood group/antibody screening analyser IVD
24 tests without support material
Biolytical Laboratories Inc
Without Support
Not in Commercial Distribution
- 06865979010207 ()
90-1020
- HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
24 Tests with support materials
Biolytical Laboratories Inc
With Support
Not in Commercial Distribution
- 06865979010184 ()
90-1018
- HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
Single
Not in Commercial Distribution
- 06865979010191 ()
90-1019
- HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution
- 00686597010198 ()
90-1019
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
AXP II Docking Station
Thermogenesis Corp.
80055
In Commercial Distribution
- 00886368000667 ()
- 10886368000664 ()
80055
- Blood centrifugation system containment kit
AXP II Device
Thermogenesis Corp.
80056
In Commercial Distribution
- 00886368000612 ()
- 10886368000619 ()
80056
- Blood centrifugation system containment kit
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-0013-0264
900-001
- Haemoglobin analyser IVD, point-of-care
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-0013-0264
In Commercial Distribution
- 04048534001946 ()
900-001
- Haemoglobin analyser IVD, point-of-care
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
No Description
BSL Co.,Ltd
ACPU-100
In Commercial Distribution
- 08800080260026 ()
- 08800080260019 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-SS-100
In Commercial Distribution
- 08800080211028 ()
- 08800080211011 ()
- 08800080211035 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-40201
In Commercial Distribution
- 08800080202224 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-24201
In Commercial Distribution
- 08800080202217 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-6020
In Commercial Distribution
- 08800080202200 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1240
In Commercial Distribution
- 08800080202194 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2460
In Commercial Distribution
- 08800080202187 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4001
In Commercial Distribution
- 08800080202170 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2401
In Commercial Distribution
- 08800080202163 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1201
In Commercial Distribution
- 08800080202156 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-601
In Commercial Distribution
- 08800080202149 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-401
In Commercial Distribution
- 08800080202132 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-201
In Commercial Distribution
- 08800080202125 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-101
In Commercial Distribution
- 08800080202118 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4040
In Commercial Distribution
- 08800080202101 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2440
In Commercial Distribution
- 08800080202095 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4060
In Commercial Distribution
- 08800080202088 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4000
In Commercial Distribution
- 08800080202071 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2400
In Commercial Distribution
- 08800080202064 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1200
In Commercial Distribution
- 08800080202057 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-600
In Commercial Distribution
- 08800080202040 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-400
In Commercial Distribution
- 08800080202033 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-200
In Commercial Distribution
- 08800080202026 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-100
In Commercial Distribution
- 08800080202019 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-22460
In Commercial Distribution
- 08800080201067 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-12460
In Commercial Distribution
- 08800080201050 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-22440
In Commercial Distribution
- 08800080201043 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-12440
In Commercial Distribution
- 08800080201036 ()
- Autologous adipose tissue collection/injection set