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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
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
The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
PATIENTSAFE SOLUTIONS, INC.
3.3.1
In Commercial Distribution

  • 00853209005006 ()
PTA BPA

  • Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2018
In Commercial Distribution

  • 00853023006173 ()


  • Blood bank information system application software
No Description
Cerner Corporation
Bridge2016
In Commercial Distribution

  • 00853023006104 ()


  • Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2012
In Commercial Distribution

  • 00853023006098 ()


  • Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion2015
In Commercial Distribution

  • 00853023006067 ()


  • Blood bank information system application software
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
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