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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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cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System - 00875197005608

No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Respiratory Virus Plus (RV+) Amplification Tray - 00857573006294

The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Respiratory Virus Plus (RV+) Extraction Tray - 00857573006232

The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-009-020
Not in Commercial Distribution

  • 00857573006232 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge - 00857573006133

The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-006-020
Not in Commercial Distribution

  • 00857573006133 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

FILMARRAY - 00851458005112

NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

JBAIDS - 00851458005068

JBAIDS IVD Influenza A & B Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0137
Not in Commercial Distribution

  • 00851458005068 ()
JRPD-ASY-0137

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARGENE® ADENOVIRUS R-gene KIT US - 03573026403997

ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings.
BIOMERIEUX SA
69-010B-US
Not in Commercial Distribution

  • 03573026403997 ()


  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Liat® Influenza A/B Script - 07613336129685

No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD

Simplexa™ Flu A/B & RSV Direct - 20816101025545

No Description
DIASORIN MOLECULAR LLC
MOL2650
Not in Commercial Distribution

  • 20816101025545 ()
MOL2650

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Flu A/B & RSV - 20816101025538

No Description
DIASORIN MOLECULAR LLC
MOL2600
In Commercial Distribution

  • 20816101025538 ()
MOL2600

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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