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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
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