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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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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

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
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