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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 - 15420045500662

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio TIGRIS Controls Mag 3.3
Not in Commercial Distribution

  • 15420045500662 ()
302193

  • 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 - 15420045500648

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

  • 15420045500648 ()
301108

  • 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 - 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)

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)

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)

Procleix - 15420045500372

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

  • 15420045500372 ()
302573

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

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR - 00840828100847

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable

cobas® HBV - 00875197006414

No Description
Roche Molecular Systems, Inc.
09040820190
In Commercial Distribution

  • 00875197006414 ()
09040820190

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

cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System - 00875197004885

No Description
Roche Diagnostics GmbH
07000979190
In Commercial Distribution

  • 00875197004885 ()
07000979190

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

cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems - 00875197004717

No Description
Roche Diagnostics GmbH
06998836190
In Commercial Distribution

  • 00875197004717 ()
06998836190

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

COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 - 00875197002706

No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197002706 ()
05027012190

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

COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent - 00875197002034

No Description
Roche Molecular Systems, Inc.
03587797190
In Commercial Distribution

  • 00875197002034 ()
03587797190

  • Buffered wash solution IVD

COBAS® TaqMan® HBV Test, For Use With The High Pure System - 00875197002003

No Description
Roche Molecular Systems, Inc.
03577163190
In Commercial Distribution

  • 00875197002003 ()
03577163190

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

High Pure System Viral Nucleic Acid Kit - 04038377020556

No Description
Roche Molecular Systems, Inc.
03502295001
In Commercial Distribution

  • 04038377020556 ()
03502295001

  • Nucleic acid extraction/isolation kit IVD

DOCKING STATION SHORT - 04015630936557

No Description
Roche Molecular Systems, Inc.
28127387001
In Commercial Distribution

  • 04015630936557 ()
28127387001

  • Nucleic acid sample preparation instrument IVD

Aptima® - 15420045506770

Aptima® HBV Quant Assay Target Enhancer Reagent.
Hologic, Inc.
KIT, TER, HBV, VL, 100T, US IVD
In Commercial Distribution

  • 15420045506770 ()
PRD-04081

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent
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