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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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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)

Tubigrip® - 05055158005280

Tubigrip B Natural 0.5m 7x12pcs
Mölnlycke Health Care AB
1510
In Commercial Distribution

  • 07332551943400 ()
  • 05055158005297 ()
  • 05055158005280 ()

  • B


  • Tubular support bandage, Hevea-latex

Oxford Partial Knee System - 05019279403899

Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422854
In Commercial Distribution

  • 05019279403899 ()

  • B
32-422854

  • Surgical implant template, reusable

Oxford Partial Knee System - 05019279403882

Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution

  • 05019279403882 ()

  • B
32-422853

  • Surgical implant template, reusable

Tubigrip® - 07332551449797

Tubigrip B Beige x 10m
Mölnlycke Health Care AB
1449
In Commercial Distribution

  • 07332551449780 ()
  • 07332551449797 ()
  • 07332551948184 ()

  • B


  • Tubular support bandage, Hevea-latex

Tubigrip® - 07332551449438

Tubigrip B Natural x 10m
Mölnlycke Health Care AB
1436
In Commercial Distribution

  • 07332551449421 ()
  • 07332551449438 ()
  • 07332551947903 ()

  • B


  • Tubular support bandage, Hevea-latex

Tubigrip® - 07332551448707

Tubigrip B Nat 1m 5x12pcs
Mölnlycke Health Care AB
1520
In Commercial Distribution

  • 07332551945879 ()
  • 07332551448684 ()
  • 07332551448707 ()

  • B


  • Tubular support bandage, Hevea-latex

CARDINAL HEALTH - 10888439712711

GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB873
In Commercial Distribution

  • 50888439712719 ()
  • 10888439712711 ()
SMA36LB873

  • Laparoscopic 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

CARDINAL HEALTH - 10888439087529

GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB871
In Commercial Distribution

  • 50888439087527 ()
  • 10888439087529 ()
SMA36LB871

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

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

n/a - E0HM740BB231

B&B Bur Block
Hager & Meisinger Gesellschaft mit beschränkter Haftung
0BB23
In Commercial Distribution

  • E0HM740BB231 ()
0BB23

  • Diamond dental bur, reusable

Cleaner15™ Rotational Thrombectomy System - 00886333222339

Cleaner15™ Rotational Thrombectomy System 7F x 135cm
ARGON MEDICAL DEVICES, INC.
700115
In Commercial Distribution

  • 00886333222339 ()

  • 7F x 135cm
700115

  • Thrombectomy rotational catheter

Cleaner XT™ Rotational Thrombectomy System - 00886333222322

Cleaner XT™ Rotational Thrombectomy System 6F x 135cm
ARGON MEDICAL DEVICES, INC.
700109XT
In Commercial Distribution

  • 00886333222322 ()

  • 6F x 135cm
700109XT

  • Thrombectomy rotational catheter

Cleaner15™ Rotational Thrombectomy System - 00886333222315

Cleaner15™ Rotational Thrombectomy System 7F x 65cm
ARGON MEDICAL DEVICES, INC.
700015
In Commercial Distribution

  • 00886333222315 ()

  • 7F x 65cm
700015

  • Thrombectomy rotational catheter

Cleaner XT™ Rotational Thrombectomy System - 00886333222308

Cleaner XT™ Rotational Thrombectomy System 6F x 65cm
ARGON MEDICAL DEVICES, INC.
700009XT
In Commercial Distribution

  • 00886333222308 ()

  • 6F x 65cm
700009XT

  • Thrombectomy rotational catheter

Trinity Biotech - 05391516748858

Clostridium difficile Antitoxin, 3 mL
MARDX DIAGNOSTICS, INC.
B1029-70C
In Commercial Distribution

  • 05391516748858 ()
B1029-70C

  • Clostridium difficile antigen IVD, reagent

Trinity Biotech - 05391516748841

Toxi-Titer Diluent, 50 mL
MARDX DIAGNOSTICS, INC.
B1029-70B
In Commercial Distribution

  • 05391516748841 ()
B1029-70B

  • Clostridium difficile antigen IVD, reagent

ALBAcyte Orr cells - 05060242471155

2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.
ALBA BIOSCIENCE LIMITED
Z421U
In Commercial Distribution

  • 05060242471155 ()


  • Group O Rh (D) negative reagent red blood cell IVD, antigen

Procleix Ultrio Elite Assay - 00859882007696

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Positive Calibrator Kit
In Commercial Distribution

  • 00859882007696 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007689

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrator Kit
In Commercial Distribution

  • 00859882007689 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007672

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 1
In Commercial Distribution

  • 00859882007672 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007665

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 1
In Commercial Distribution

  • 00859882007665 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007603

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Discriminatory Probe Kit
In Commercial Distribution

  • 00859882007603 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007597

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
High Volume Calibrator Kit
In Commercial Distribution

  • 00859882007597 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007580

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 4
In Commercial Distribution

  • 00859882007580 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007573

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007573 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007566

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007566 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007559

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Low Volume Calibrator Kit
In Commercial Distribution

  • 00859882007559 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007542

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 4
In Commercial Distribution

  • 00859882007542 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007535

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 3
In Commercial Distribution

  • 00859882007535 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Elite Assay - 00859882007528

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 2
In Commercial Distribution

  • 00859882007528 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

AFFIRMAGEN - 10758750003914

0.8% Affirmagen® 3 (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719211
In Commercial Distribution

  • 10758750003914 ()
719211

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
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