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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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Dealmed - 00817415020963

Strep A Test CLIA Waived 25/Box
DEALMED MEDICAL SUPPLIES LLC
788025
In Commercial Distribution

  • 00817415020307 ()
  • 00817415020963 ()
788025

  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini - 00815381020765

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424589
In Commercial Distribution

  • 00815381020765 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini - 00815381020727

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424537
In Commercial Distribution

  • 00815381020727 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel - 00815381020659

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424461
In Commercial Distribution

  • 00815381020659 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Respiratory Panel 2.1 - 00815381020529

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423742
In Commercial Distribution

  • 00815381020529 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Respiratory Panel 2.1 EUA - 00815381020482

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel - 00815381020390

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423485
In Commercial Distribution

  • 00815381020390 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Pneumonia Panel plus (Pneumoplus) - 00815381020321

IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0142
In Commercial Distribution

  • 00815381020321 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Pneumonia Panel plus (Pneumoplus) - 00815381020314

IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0143
In Commercial Distribution

  • 00815381020314 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Respiratory Panel 2 plus (RP2plus) - 00815381020307

IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0137
Not in Commercial Distribution

  • 00815381020307 ()
RFIT-ASY-0137

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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