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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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RL-500 - 08809315679817

Hose 1ea, Com cable 1ea (1 set box)
DAESUNG MAREF CO.,LTD.
1000860
In Commercial Distribution

  • 18809315679814 ()
  • 08809315679817 ()
  • 28809315679811 ()


  • Hand/wrist continuous passive motion exerciser

Portrait Toxigenic C. difficile Assay - B178GBCDIFF100

C. diff Assay Cartridge and Sample Prep Device.
GREAT BASIN SCIENTIFIC, INC.
GBCDIFF-10
In Commercial Distribution

  • B178GBCDIFF100 ()
  • B178GBCDIFF102 ()
GBCDIFF-10

  • Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Trinity Biotech - 05391516748780

Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206631
In Commercial Distribution

  • 05391516748780 ()
1206631

  • Clostridium difficile toxin A/B antigen IVD, control

Trinity Biotech - 05391516747936

Clostridium difficile Toxin Control, 1.0 mL
MARDX DIAGNOSTICS, INC.
B1029-70A
In Commercial Distribution

  • 05391516747936 ()
B1029-70A

  • Clostridium difficile toxin A/B antigen IVD, control

NA - 05032384005895

No Description
OXOID LIMITED
CT0044B
In Commercial Distribution

  • 05032384005895 ()
  • 05032384501946 ()


  • Polymixin B susceptibility testing disc IVD

RSV Positive Control - 00840733103476

RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
751110
In Commercial Distribution

  • 00840733103476 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control

FLU/RSV Positive Control - 00840733101977

FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
MERIDIAN BIOSCIENCE, INC.
751110
Not in Commercial Distribution

  • 00840733101977 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control

RDS - 10694644700029

RSV Test Kit European 135065
AMERICAN BIO MEDICA CORPORATION
10-RSV-065
In Commercial Distribution

  • 10694644700029 ()
  • 10694644750024 ()
10-RSV-065

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

Easy Lab Pro RSV - 10694644700036

Easy Lab Pro RSV - US
AMERICAN BIO MEDICA CORPORATION
10-RSV-ELP
In Commercial Distribution

  • 10694644750031 ()
  • 10694644700036 ()
10-RSV-ELP

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

RDS - 10694644700012

RSV Test Kit US Version 135060
AMERICAN BIO MEDICA CORPORATION
10-RSV-060
In Commercial Distribution

  • 10694644700012 ()
  • 10694644750017 ()
10-RSV-060

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
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