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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 - 15420045500471

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

  • 15420045500471 ()
302576

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

Procleix - 15420045500464

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

  • 15420045500464 ()
302571

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

Procleix - 15420045500457

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

  • 15420045500457 ()
302574

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

Procleix - 15420045500440

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

  • 15420045500440 ()
302574

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

Procleix - 15420045500433

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

  • 15420045500433 ()
302574

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

Procleix - 15420045500426

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

  • 15420045500426 ()
302574

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

Procleix - 15420045500419

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

  • 15420045500419 ()
302574

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

Procleix - 15420045500402

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

  • 15420045500402 ()
302573

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

Procleix - 15420045500396

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

  • 15420045500396 ()
302573

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

Procleix - 15420045500389

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

  • 15420045500389 ()
302573

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