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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® Respiratory Panel 2 (RP2) - 00815381020154

IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0129
Not in Commercial Distribution

  • 00815381020154 ()
RFIT-ASY-0129

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

FilmArray® Respiratory Panel (RP) EZ - 00815381020147

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

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

FilmArray® Respiratory Panel (RP) - 00815381020079

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

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

FilmArray® Respiratory Panel (RP) - 00815381020062

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

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

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)

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

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)

Medical Action Industries - 10809160003732

Inst: Scissor Curv 4.5in B/B 20/Bx
MEDICAL ACTION INDUSTRIES INC.
73649
In Commercial Distribution

  • 20809160003739 ()
  • 10809160003732 ()
  • 30809160003736 ()


  • General-purpose surgical scissors, single-use

Telio Desensitizer - DVIV707177AN1

FLK Syntac Adhesive B, FLK Syntac Adhesive B
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
707177AN
Not in Commercial Distribution

  • DIVO707177AN0 ()
  • DVIV707177AN1 ()
707177AN

  • Dental coating, tooth-desensitizing, professional
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