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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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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 7F x 65cm
ARGON MEDICAL DEVICES, INC.
700015
In Commercial Distribution

  • 00886333222315 ()

  • 7F x 65cm
700015

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

  • 00886333222308 ()

  • 6F x 65cm
700009XT

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

  • 05391516748858 ()
B1029-70C

  • Clostridium difficile antigen IVD, reagent
Toxi-Titer Diluent, 50 mL
MARDX DIAGNOSTICS, INC.
B1029-70B
In Commercial Distribution

  • 05391516748841 ()
B1029-70B

  • Clostridium difficile antigen IVD, reagent
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)
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)
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)
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)
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)
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