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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
BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
CARTER BLOODCARE
v3.01
In Commercial Distribution
- 00857222008037 ()
- Blood bank information system application software
iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfusion requirements, patients’ blood specimen tests, and patient laboratory results.
eLIS provides the blood bank laboratory with:
* Patient management
* Request order management
* Patient testing management
* Product order and fulfillment management including an interface to the blood center’s product inventory
* Computer crossmatch and manual crossmatch data management
* Interfaces to laboratory instruments.
Trained laboratory personnel use eLIS to record patient information, manage specimens, enter single and batch test orders, and maintain test results.
In concert with inventory control modules in other blood establishment computer software, eLIS can be used to complete cross match of a patient’s requirements with products in inventory, manage blood orders and maintain product data related to patient transfusions.
CARTER BLOODCARE
1.0
In Commercial Distribution
- 00857222008013 ()
- Blood bank information system application software
BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
CARTER BLOODCARE
2.06
In Commercial Distribution
- 00857222008006 ()
- Blood bank information system application software
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
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
For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution
- 14086000101421 ()
- 04086000101424 ()
- 24086000101428 ()
4R2335H
- Blood transfer set
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution
- 00850034511979 ()
- 00850034511962 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution
- 00850034511429 ()
- 00850034511597 ()
- Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution
- 00850034511559 ()
- 00850034511573 ()
- Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A15
In Commercial Distribution
- 00850034511535 ()
- 00850034511566 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution
- 00850034511498 ()
- Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution
- 00850034511474 ()
- 00850034511450 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HDPRP30
In Commercial Distribution
- 00850034511405 ()
- 00850034511412 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HDPRP15
In Commercial Distribution
- 10850034511310 ()
- 00850034511313 ()
- Haematological concentrate system
A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Bimini Technologies LLC
AMPLIFINE
In Commercial Distribution
- 00850034511887 ()
- 00850034511290 ()
- Haematological concentrate system preparation kit, platelet concentration
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A15
In Commercial Distribution
- 00850034511221 ()
- 00850034511214 ()
- Haematological concentrate system
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
No Description
VERICEL CORPORATION
366643
In Commercial Distribution
- 00850037506156 ()
- Evacuated blood collection tube IVD, anticoagulant
No Description
EPIC SYSTEMS CORPORATION
4
In Commercial Distribution
- 00850053416002 ()
- Blood bank information system application software
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution
- 00850025688826 ()
- Home pharmaceutical management support software
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution
- 00850025688819 ()
- Home pharmaceutical management support software
The alVeo Autologous Fibrin & Platelet 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.
ROYAL BIOLOGICS INC.
510354
In Commercial Distribution
- 10850014593640 ()
- 00850014593643 ()
- Total Volume: 60 Milliliter
510354
- Haematological concentrate system preparation kit, platelet concentration
The SeriVium Autologous Fibrin & Platelet 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.
ROYAL BIOLOGICS INC.
510355
In Commercial Distribution
- 10850014593633 ()
- 00850014593636 ()
- Total Volume: 60 Milliliter
510355
- Haematological concentrate system preparation kit, platelet concentration
The BioIncyte Autologous Fibrin & Platelet 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.
ROYAL BIOLOGICS INC.
510356
In Commercial Distribution
- 10850014593626 ()
- 00850014593629 ()
- Total Volume: 60 Milliliter
510356
- Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies.
ROYAL BIOLOGICS INC.
MXBMC-60
In Commercial Distribution
- 00850014593391 ()
- 10850014593398 ()
- Total Volume: 60 Milliliter
MXBMC-60
- Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .
ROYAL BIOLOGICS INC.
MXCB
In Commercial Distribution
- 10850014593381 ()
- 00850014593384 ()
- Total Volume: 60 Milliliter
MXCB-1
- Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and phlebotomy supplies.
ROYAL BIOLOGICS INC.
MXPRP
In Commercial Distribution
- 10850014593374 ()
- 00850014593377 ()
- Total Volume: 60 Milliliter
MXPRP-1
- Haematological concentrate system preparation kit, platelet concentration
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530101-1
In Commercial Distribution
- 00850034511955 ()
- 00850034511948 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution
- 00850034511832 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution
- 00850034511443 ()
- 00850034511580 ()
- Haematological concentrate system
A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Bimini Technologies LLC
GAAPS-25
In Commercial Distribution
- 00850034511900 ()
- 00850034511269 ()
- Haematological concentrate system preparation kit, platelet concentration
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
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
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members
BUOY SOFTWARE, LLC
1
In Commercial Distribution
- 00860010651209 ()
- Blood bank information system application software
Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.5A
In Commercial Distribution
- 00860010612866 ()
4
- Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
QTX - V1.1a(WinSQL 1.0c)
In Commercial Distribution
- 00860010612859 ()
6
- Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
QTX - V1.0e(WinSQL 1.0d)
In Commercial Distribution
- 00860010612842 ()
5
- Blood bank information system application software
Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution
- 00860010612835 ()
4
- Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution
- 00860010612828 ()
3
- Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution
- 00860010612811 ()
2
- Blood bank information system application software