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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 - 15420045500532

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

  • 15420045500532 ()
301103C

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

Procleix - 15420045500525

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

  • 15420045500525 ()
303261

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

Procleix - 15420045500518

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

  • 15420045500518 ()
303260

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

Procleix - 15420045500501

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

  • 15420045500501 ()
302575

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

Procleix - 15420045500495

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

  • 15420045500495 ()
302572

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

Procleix - 15420045500488

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

  • 15420045500488 ()
302577

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

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)
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