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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 - 00850032683012

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 - 00850032683005

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

PK7400 - 14987666543344

PK7400 Automated Microplate System
Beckman Coulter, Inc.
B53299
In Commercial Distribution

  • 14987666543344 ()


  • Blood group/antibody screening analyser IVD

PK7300 - 14987666535721

PK7300
Beckman Coulter, Inc.
N3209000
In Commercial Distribution

  • 14987666535721 ()
N3209000

  • Blood group/antibody screening analyser IVD

INSTI HIV-1/HIV-2 Antibody Test - 06865979010207

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

INSTI HIV-1/HIV-2 Antibody Test - 06865979010184

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

INSTI HIV-1/HIV-2 Antibody Test - 06865979010191

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

INSTI HIV-1/HIV-2 Antibody Test - 00686597010198

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

ThermoGenesis AutoXpress - 10886368000664

AXP II Docking Station
Thermogenesis Corp.
80055
In Commercial Distribution

  • 00886368000667 ()
  • 10886368000664 ()
80055

  • Blood centrifugation system containment kit

ThermoGenesis AXP - 10886368000619

AXP II Device
Thermogenesis Corp.
80056
In Commercial Distribution

  • 00886368000612 ()
  • 10886368000619 ()
80056

  • Blood centrifugation system containment kit
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