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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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Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369250

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369250 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369243

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369243 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Panther Fusion® - 15420045510890

The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA.
Hologic, Inc.
KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVD
In Commercial Distribution

  • 15420045510890 ()
PRD-04484

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

NovaLisa Influenza Virus B IgG - ENTIINFG03000

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

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)

B&B Bubbler - 00850008733055

Water Seal CPAP Valve, 24 units
B&B Medical Technologies
25324
In Commercial Distribution

  • 00850008733055 ()
25324

  • PEEP valve, single-use

B&B Bubbler - 00850008733031

Water Seal CPAP Valve, 12 units
B&B Medical Technologies
25312
In Commercial Distribution

  • 00850008733031 ()
25312

  • PEEP valve, single-use

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

ACCURUN® - 00850041090108

No Description
Lgc Clinical Diagnostics, Inc.
2000-0107
In Commercial Distribution

  • 00850041090108 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00850041090092

No Description
Lgc Clinical Diagnostics, Inc.
2000-0106
In Commercial Distribution

  • 00850041090092 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00850041090061

No Description
Lgc Clinical Diagnostics, Inc.
2000-0105
In Commercial Distribution

  • 00850041090061 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System - 00875197005639

No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control

MAS anti-HBs Positive Control - 00884883007529

No Description
Microgenics Corporation
10027482
In Commercial Distribution

  • 00884883007529 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

MAS anti-HBs Positive Control – For use with Siemens Assays - 00884883007383

No Description
Microgenics Corporation
10027482-U
In Commercial Distribution

  • 00884883007383 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix AntiHBs - 00884883006942

No Description
Microgenics Corporation
960855
Not in Commercial Distribution

  • 00884883006942 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV High Control - 00884883006553

No Description
Microgenics Corporation
965003
In Commercial Distribution

  • 00884883006553 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV Mid Control - 00884883006508

No Description
Microgenics Corporation
965002
In Commercial Distribution

  • 00884883006508 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV Low Control - 00884883006492

No Description
Microgenics Corporation
965001
In Commercial Distribution

  • 00884883006492 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix BB NAT HBV Positive Control - 00884883006027

No Description
Microgenics Corporation
963603
In Commercial Distribution

  • 00884883006027 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
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