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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 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
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
LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution

  • 10888234500841 ()
628220

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution

  • 10888234500827 ()
628515UDI

  • Buffered sample diluent IVD
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution

  • 10888234500810 ()
888627

  • Laboratory instrument/analyser application software IVD
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