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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 - 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 - 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)

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® Wash Reagent - 00875197002034

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

  • 00875197002034 ()
03587797190

  • Buffered wash solution IVD

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

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® 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® 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)

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

Aptima® - 15420045506749

The Aptima® HBV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.
Hologic, Inc.
KIT, MAIN ASSAY, HBV, VL, 100T, US IVD
In Commercial Distribution

  • 15420045506749 ()
ASY-10269

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

Alinity m - 00884999050808

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03B
In Commercial Distribution

  • 00884999050808 ()
08N47-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048645

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution

  • 00884999048645 ()
08N47-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999047754

Alinity m HBV AMP Kit
ABBOTT MOLECULAR INC.
08N47-095
In Commercial Distribution

  • 00884999047754 ()
08N47-095

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

RealTime - 00884999042667

Abbott RealTime HBV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
02N43-004
In Commercial Distribution

  • 00884999042667 ()
02N43-004

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999038462

Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-91
In Commercial Distribution

  • 00884999038462 ()
2N40-91

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

RealTime - 00884999037762

Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution

  • 00884999037762 ()
2N43-03

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999003071

Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

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

CARDINAL HEALTH - 10885425743797

B B SCISSORS 5.5
Cardinal Health 200, LLC
12A8426B
In Commercial Distribution

  • 50885425743795 ()
  • 10885425743797 ()
12A8426B

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439195606

GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB872
In Commercial Distribution

  • 50888439195604 ()
  • 10888439195606 ()
SMA36LB872

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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