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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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Epstein-Barr virus (EBV) Primers ASR.
Hologic, Inc.
DNA EBV PRIMERS (ASR)
In Commercial Distribution

  • 15420045511446 ()
PRD-04988

  • Epstein-Barr virus (EBV) nucleic acid IVD, reagent
Cytomegalovirus (CMV) Probe ASR.
Hologic, Inc.
DNA CMV PROBE (ASR)
In Commercial Distribution

  • 15420045511439 ()
PRD-04986

  • Cytomegalovirus (CMV) nucleic acid IVD, reagent
Cytomegalovirus (CMV) Primers ASR.
Hologic, Inc.
DNA CMV Primers (ASR)
In Commercial Distribution

  • 15420045511422 ()
PRD-04985

  • Cytomegalovirus (CMV) nucleic acid IVD, reagent
The RNA IC Probe ASR contains an oligonucleotide designed to detect the RNA target present in the Panther Fusion® Internal Control-S reagent.
Hologic, Inc.
RNA, IC Probe (ASR)
In Commercial Distribution

  • 15420045511415 ()
PRD-04309

  • Exogenous DNA/RNA internal control IVD, kit
The DNA IC Probe ASR contains an oligonucleotide designed to detect the DNA target present in the Panther Fusion® Internal Control-S and Panther Fusion® Internal Control-X reagents.
Hologic, Inc.
DNA, IC Probe (ASR)
In Commercial Distribution

  • 15420045511408 ()
PRD-04308

  • Exogenous DNA/RNA internal control IVD, kit
The RNA IC Primers ASR contains forward and reverse primers designed to amplify the RNA target present in the Panther Fusion® Internal Control-S reagent.
Hologic, Inc.
RNA, IC Primers (ASR)
In Commercial Distribution

  • 15420045511392 ()
PRD-04307

  • Exogenous DNA/RNA internal control IVD, kit
The DNA IC Primers ASR contains forward and reverse primers designed to amplify the DNA targets present in the Panther Fusion® Internal Control-S and Panther Fusion® Internal Control-X reagents.
Hologic, Inc.
DNA, IC Primers (ASR)
In Commercial Distribution

  • 15420045511088 ()
PRD-04306

  • Exogenous DNA/RNA internal control IVD, kit
Panther Fusion® Open Access® Diluent Additive.
Hologic, Inc.
LBLD, DILUENT ADDITIVE, OPEN ACCESS
In Commercial Distribution

  • 15420045511071 ()
PRD-04945

  • Nucleic acid technique (NAT) kit IVD
Aptima® HCV Quant Dx Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HCV QUANT, US IVD
In Commercial Distribution

  • 15420045506800 ()
PRD-03707

  • Hepatitis C virus nucleic acid IVD, calibrator
Aptima® HCV Quant Dx Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HCV QUANT, US IVD
In Commercial Distribution

  • 15420045506794 ()
PRD-03706

  • Hepatitis C virus nucleic acid IVD, control
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