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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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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
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
Aptima® HBV Quant Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HBV, VL, US IVD
In Commercial Distribution

  • 15420045506763 ()
PRD-03869

  • Hepatitis B virus nucleic acid IVD, control
Aptima® HBV Quant Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HBV VL, US IVD
In Commercial Distribution

  • 15420045506756 ()
PRD-03872

  • Hepatitis B virus nucleic acid IVD, calibrator
Aptima® HIV-1 Quant Dx Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HIV QUANT, US IVD
In Commercial Distribution

  • 15420045504233 ()
PRD-03567

  • HIV1 nucleic acid IVD, control
Aptima® HIV-1 Quant Dx Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATORS, HIV QUANT, US IVD
In Commercial Distribution

  • 15420045504226 ()
PRD-03566

  • HIV1 nucleic acid IVD, calibrator
No Description
Hologic, Inc.
KIT, APTIMA, HCVQL, FROZEN, IVD, (BOX 1)
Not in Commercial Distribution

  • 15420045500211 ()
302130

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
KIT,APTIMA,HIV-1QL,FROZEN,IVD,(BOX 1)
Not in Commercial Distribution

  • 15420045500174 ()
302142

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
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