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

  • 00884999050808 ()
08N47-03B

  • Laboratory instrument/analyser application software IVD
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 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)
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
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)
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
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)
B B SCISSORS 5.5
Cardinal Health 200, LLC
12A8426B
In Commercial Distribution

  • 50885425743795 ()
  • 10885425743797 ()
12A8426B

  • General surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB872
In Commercial Distribution

  • 50888439195604 ()
  • 10888439195606 ()
SMA36LB872

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB871
In Commercial Distribution

  • 50888439087527 ()
  • 10888439087529 ()
SMA36LB871

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB873
In Commercial Distribution

  • 50888439712719 ()
  • 10888439712711 ()
SMA36LB873

  • Laparoscopic surgical procedure kit, non-medicated, single-use
B&B Bur Block
Hager & Meisinger Gesellschaft mit beschränkter Haftung
0BB23
In Commercial Distribution

  • E0HM740BB231 ()
0BB23

  • Diamond dental bur, reusable
Tubigrip B Natural 0.5m 7x12pcs
Mölnlycke Health Care AB
1510
In Commercial Distribution

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

  • B


  • Tubular support bandage, Hevea-latex
Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422854
In Commercial Distribution

  • 05019279403899 ()

  • B
32-422854

  • Surgical implant template, reusable
Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution

  • 05019279403882 ()

  • B
32-422853

  • Surgical implant template, reusable
Tubigrip B Beige x 10m
Mölnlycke Health Care AB
1449
In Commercial Distribution

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

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Nat 1m 5x12pcs
Mölnlycke Health Care AB
1520
In Commercial Distribution

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

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Natural x 10m
Mölnlycke Health Care AB
1436
In Commercial Distribution

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

  • B


  • Tubular support bandage, Hevea-latex
Clostridium difficile Antitoxin, 3 mL
MARDX DIAGNOSTICS, INC.
B1029-70C
In Commercial Distribution

  • 05391516748858 ()
B1029-70C

  • Clostridium difficile antigen IVD, reagent
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