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STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution
- 00385480306461 ()
30646
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution
- 00385480306454 ()
30645
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution
- 00385480306447 ()
30644
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution
- 00385480306430 ()
30643
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution
- 00385480278966 ()
- 00385489278967 ()
27896
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution
- 00385480239332 ()
23933
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution
- 00385480239325 ()
23932
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution
- 00385480239318 ()
23931
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution
- 00385480239301 ()
23930
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution
- 00385480227636 ()
- 00385489227637 ()
22763
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used
for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of
care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling
characteristics. The FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5
individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier with
insert and cap and 1 - 50 mL Falcon® tube.
VERTICAL SPINE, LLC
510357
In Commercial Distribution
- 30851802007084 ()
- 10851802007080 ()
- Total Volume: 50 Milliliter
510357
- Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5).
The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510358
In Commercial Distribution
- 30851802007077 ()
- 10851802007073 ()
- Total Volume: 27 Milliliter
510358
- Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5).
The 45 mL FIBRINET® System contains 5 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510359
In Commercial Distribution
- 30851802007060 ()
- 10851802007066 ()
- Total Volume: 45 Milliliter
510359
- Haematological concentrate system preparation kit, platelet concentration
RBC DE-GLYCEROL./CELL WASH SET
HAEMONETICS CORPORATION
00235-00
In Commercial Distribution
- 30812747015015 ()
- 10812747015011 ()
- Total Volume: 225 Milliliter
- Total Volume: 5 Liter
- Total Volume: 600 Milliliter
- Blood cell freeze/thaw system set
RBC GLYCEROLIZATION SET
HAEMONETICS CORPORATION
00225-00
In Commercial Distribution
- 30812747015008 ()
- 10812747015004 ()
- Blood cell freeze/thaw system set
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution
- 04086000101516 ()
- Apheresis system
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2367
In Commercial Distribution
- 14086000100998 ()
- 04086000100991 ()
4R2367
- Apheresis system tubing set
For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2365
In Commercial Distribution
- 04086000100984 ()
- 14086000100981 ()
4R2365
- Apheresis system tubing set
Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Fresenius Kabi AG
6R4601
In Commercial Distribution
- 04086000100236 ()
6R4601
- Apheresis system
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5720
In Commercial Distribution
- 04086000100199 ()
- 14086000100196 ()
X4R5720
- Apheresis system tubing set
ADAM-rWBC System is composted ADAM-rWBC(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 human specimen.
NanoEnTek, Inc.
ADAM-rWBC System
In Commercial Distribution
- 08809317540276 ()
ADAM-rWBC System
- White blood cell count IVD, kit, cell count
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
NanoEnTek, Inc.
AD1K-050
In Commercial Distribution
- 08809317540269 ()
AD1K-050
- White blood cell count IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution
- 10888234500513 ()
404573
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution
- 10888234500506 ()
404572
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution
- 10888234500469 ()
404558
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution
- 10888234500452 ()
404557
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution
- 10888234500223 ()
PAK12G
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution
- 10888234500612 ()
404597
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution
- 10888234500605 ()
404596
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12
Not in Commercial Distribution
- 10888234500216 ()
PAK12
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS).
ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution
- 10888234002475 ()
- Laboratory instrument/analyser application software IVD
Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
HAEMONETICS CORPORATION
732-83
In Commercial Distribution
- 30887691310691 ()
- 10887691310697 ()
- Blood/tissue storage/culture container
Automated Blood Collection System
TERUMO BCT, INC.
81002
In Commercial Distribution
- 05020583810020 ()
- Apheresis system
Automated Blood Collection System
TERUMO BCT, INC.
81000
In Commercial Distribution
- 05020583810006 ()
- Apheresis system
Terumo Sterile Tubing Welder
TERUMO BCT, INC.
62000
In Commercial Distribution
- 05020583620001 ()
- Package sealing unit
Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution
- 05020583252035 ()
- Blood bank information system
Information System Version 4, Vista Standard Interface and SafeTrace®
BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution
- 05020583252028 ()
- Blood bank information system
Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution
- 05020583252011 ()
- Blood bank information system
Single-Needle Extended Life Platelet Set With LRS® Chamber
TERUMO BCT, INC.
70400
Not in Commercial Distribution
- 05020583704008 ()
- 35020583704009 ()
- Blood transfer set
Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution
- 05020583620018 ()
- Package sealing unit
ART PRP 2-Step Processing Kit - Mini - w/o blood draw
Celling Biosciences
1651-0002
In Commercial Distribution
- 00817771028870 ()
1651-0002
- Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Processing Kit - 120
Celling Biosciences
1651-0005
In Commercial Distribution
- 00817771028856 ()
1651-0005
- Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Processing Kit - 60
Celling Biosciences
1651-0004
In Commercial Distribution
- 00817771028825 ()
1651-0004
- Haematological concentrate system preparation kit, platelet concentration
NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010187 ()
- Blood bank information system application software
SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010101 ()
- Blood bank information system application software
BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010002 ()
- Clinical laboratory information system application software
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution
- 07611969965731 ()
805200100
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution
- 07611969950898 ()
805200100
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution
- 30812747011970 ()
- Autotransfusion system blood component processing set
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5720
In Commercial Distribution
- 10811137010124 ()
- 00811137010127 ()
4R5720
- Apheresis system tubing set