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The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
718463
In Commercial Distribution
- 00866489000012 ()
718463
- Electronic pipette
The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution
- 00866305000264 ()
- Length: 33 Centimeter
- Height: 9.9 Centimeter
- Width: 14.2 Centimeter
- Weight: 2.5 Kilogram
480-RW-2607-02
- Laboratory tubing welder
The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution
- 00866305000219 ()
- Weight: 1.6 Kilogram
- Width: 9.1 Centimeter
- Length: 27.2 Centimeter
- Height: 5.9 Centimeter
480-B40-00-1245
- Laboratory tubing welder
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution
- 00866305000202 ()
- Weight: 2.5 Kilogram
- Width: 14.2 Centimeter
- Height: 9.9 Centimeter
- Length: 33 Centimeter
480-RW-2607-00
- Laboratory tubing welder
No Description
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution
- 00863626000201 ()
- Cryopreserved blood/tissue thawing unit
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Client Server
In Commercial Distribution
- 00863529000117 ()
- Blood bank information system application software
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution
- 00863529000100 ()
- Blood bank information system application software
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution
- 00860007397615 ()
- Blood bank information system application software
LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems.
Csl Plasma Inc.
4.0
In Commercial Distribution
- 00860007397608 ()
- Blood bank information system application software
e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution
- 00860007282744 ()
- Blood bank information system
Surround 5.x
Gpi Usa, Inc.
5.x
- Blood bank information system
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
- Configurable electronic form web-based application software
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
- Blood bank information system
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution
- 00860006793708 ()
2.0.0.0
- Blood bank information system application software
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution
- 00851707004262 ()
AVRL0102
- Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution
- 00851707004149 ()
C3RL01-B:US
- Autologous skin cell grafting kit
30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG053
In Commercial Distribution
- 00850060751172 ()
- 00850060751158 ()
- 10850060751179 ()
- 00850060751202 ()
PROGEN-A30
- Autologous platelet-based product centrifuge tube
30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG020
Not in Commercial Distribution
- 00850060751165 ()
- 00850060751141 ()
- 10850060751162 ()
- Autologous platelet-based product centrifuge tube
15mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG052
In Commercial Distribution
- 00850060751134 ()
- 00850060751110 ()
- 10850060751131 ()
- 00850060751196 ()
PROGEN-A15
- Autologous platelet-based product centrifuge tube
15 mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG019
Not in Commercial Distribution
- 00850060751127 ()
- 00850060751103 ()
- 10850060751124 ()
- Autologous platelet-based product centrifuge tube
Blood separation tube for PRP
Factor Medical, Inc.
0363
In Commercial Distribution
- 00851802007113 ()
- Total Volume: 9 Milliliter
0363
- Haematological concentrate system preparation kit, platelet concentration
Biowy Freezing Bag FB1000, Max Volume: 1000 mL
Biowy Corporation
FB1000
In Commercial Distribution
- 00851739007255 ()
- 00851739007033 ()
- Blood/tissue storage/culture container
Biowy Freezing Bag FB500, Max Volume: 500 mL
Biowy Corporation
FB500
In Commercial Distribution
- 00851739007248 ()
- 00851739007026 ()
- Blood/tissue storage/culture container
Biowy Freezing Bag FB250, Max Volume: 250 mL
Biowy Corporation
FB250
In Commercial Distribution
- 00851739007019 ()
- 00851739007231 ()
- Blood/tissue storage/culture container
Biowy Freezing Bag FB50, Max Volume: 50 mL
Biowy Corporation
FB50
In Commercial Distribution
- 00851739007002 ()
- 00851739007187 ()
- Blood/tissue storage/culture container
Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit
Nuo Therapeutics, Inc.
AUXP-4TR
In Commercial Distribution
- 00852714003248 ()
- Wound dressing kit, medicated
Aurix Reagent Kit Single Kit with 010110 Reagent Kit Label
Nuo Therapeutics, Inc.
AGSR-03
In Commercial Distribution
- 00852714003118 ()
- Wound dressing kit, medicated
Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution
- 00852714003101 ()
- Wound dressing kit, medicated
Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label
Nuo Therapeutics, Inc.
AGSC-04
In Commercial Distribution
- 00852714003095 ()
- General-purpose centrifuge IVD
Lattice MediCopia for Specimen Collection, Transfusion Administration, Breast Milk and Anatomic Pathology.
Lattice Incorporated
4.x.x
In Commercial Distribution
- 00860014128905 ()
- Blood bank information system application software
This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Reapplix ApS
2
In Commercial Distribution
- 05714188505503 ()
- Haematological concentrate system preparation kit, platelet concentration
This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution
- 05714188505206 ()
- Haematological concentrate system preparation kit, platelet concentration
Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).
Reapplix ApS
2
In Commercial Distribution
- 05714188505008 ()
- Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution
- 05714188502106 ()
- Haematological concentrate system preparation kit, platelet concentration
Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
Reapplix ApS
2
In Commercial Distribution
- 05714188501000 ()
- Haematological concentrate system preparation kit, platelet concentration
No Description
Roche Molecular Systems, Inc.
09040536190
In Commercial Distribution
- 00875197006483 ()
09040536190
- HIV1/HIV2 nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
09040528190
In Commercial Distribution
- 00875197006384 ()
09040528190
- HIV1/HIV2 nucleic acid IVD, control
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
No Description
EPIC SYSTEMS CORPORATION
4
In Commercial Distribution
- 00850053416002 ()
- Blood bank information system application software
No Description
VERICEL CORPORATION
366643
In Commercial Distribution
- 00850037506156 ()
- Evacuated blood collection tube IVD, anticoagulant
Procleix WNV/Babesia 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 RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
WNV Positive Control
In Commercial Distribution
- 00850032683067 ()
- West Nile virus nucleic acid IVD, control
Procleix WNV/Babesia 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 RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Babesia Positive Control
In Commercial Distribution
- 00850032683050 ()
- Multiple Babesia species nucleic acid IVD, control
Procleix WNV/Babesia 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 RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
WNV/Babesia Negative Control
In Commercial Distribution
- 00850032683043 ()
- PCR/NAT negative control IVD
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.
HBV Positive Control
In Commercial Distribution
- 00850032683036 ()
- Hepatitis B virus 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.
HCV Positive Control
In Commercial Distribution
- 00850032683029 ()
- Hepatitis C virus 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 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
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution
- 00850034511979 ()
- 00850034511962 ()
- Haematological concentrate system