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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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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) - 00815381020291

IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0136
Not in Commercial Distribution

  • 00815381020291 ()
RFIT-ASY-0136

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

Idylla™ Respiratory (IFV-RSV) Panel - 15415219000635

No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

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

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369137

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

  • 06974849369137 ()


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

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369120

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

  • 06974849369120 ()


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

GeneXpert® - 07332940008604

Xpert Xpress CoV-2/Flu/RSV plus
CEPHEID
XPRS4PLEX-10
In Commercial Distribution

  • 07332940008604 ()
XPRS4PLEX-10

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

Influenza Virus A IgG ELISA - 00404847437935

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
Not in Commercial Distribution

  • 00404847437935 ()
EIA-3793

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

IMAGEN RESPIRATORY SCREEN POS CON SLIDE - 05032384503070

No Description
OXOID LIMITED
S612130-2
In Commercial Distribution

  • 05032384503070 ()


  • Multiple-genus respiratory virus antigen IVD, control

IMAGEN Respiratory Screen Kit - 05032384503841

No Description
OXOID LIMITED
K612011-2
In Commercial Distribution

  • 05032384503841 ()


  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Anti-Influenza A Virus ELISA (IgM) - 04049016028307

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 M
Not in Commercial Distribution

  • 04049016028307 ()


  • Influenza A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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