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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 - 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 - 15420045500624

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

  • 15420045500624 ()
301106

  • 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)

Procleix - 15420045500587

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

  • 15420045500587 ()
301105C

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

Procleix - 15420045500570

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

  • 15420045500570 ()
301105C

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

Procleix - 15420045500563

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

  • 15420045500563 ()
301105C

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

Procleix - 15420045500556

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

  • 15420045500556 ()
301103C

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

Procleix - 15420045500549

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

  • 15420045500549 ()
301103C

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