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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 - 15420045500723

No Description
Hologic, Inc.
Auto Detect Reagents
Not in Commercial Distribution

  • 15420045500723 ()
301120

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500716

No Description
Hologic, Inc.
Assay Fluids
Not in Commercial Distribution

  • 15420045500716 ()
301116

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500709

No Description
Hologic, Inc.
Procleix System Fluid Preservative
Not in Commercial Distribution

  • 15420045500709 ()
301175

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500693

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Procleix Buffer for Deactivation Fluid
Not in Commercial Distribution

  • 15420045500693 ()
303666

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500679

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Procleix Oil
Not in Commercial Distribution

  • 15420045500679 ()
302441

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500655

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio HBV D-Probes
Not in Commercial Distribution

  • 15420045500655 ()
301109

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500631

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio HIV-1 D-Probes
Not in Commercial Distribution

  • 15420045500631 ()
301107

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500617

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Negative Calibrators
Not in Commercial Distribution

  • 15420045500617 ()
303259

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500600

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Neg TIGRIS Controls
Not in Commercial Distribution

  • 15420045500600 ()
303258

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500594

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio 5K
Not in Commercial Distribution

  • 15420045500594 ()
301105C

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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