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The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1035
In Commercial Distribution

  • B54010350 ()
1035

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1027
In Commercial Distribution

  • B54010270 ()
1027

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Adenovirus Assay
QUIDEL CORPORATION
Adenovirus Assay
In Commercial Distribution

  • 30014613311133 ()
M113

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana RSV/hMPB Assay
DIAGNOSTIC HYBRIDS, INC.
M306
In Commercial Distribution

  • 30014613336143 ()
M306

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Flu kit; 10 test kit
CEPHEID
XPRSFLU-10
In Commercial Distribution

  • 07332940006044 ()
XPRSFLU-10

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Flu/RSV kit; 10 test kit
CEPHEID
XPRSFLU/RSV-10
In Commercial Distribution

  • 07332940005696 ()
XPRSFLU/RSV-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Flu+RSV Xpress kit; 10 test kit
CEPHEID
GXFLU+RSV-XP-10
Not in Commercial Distribution

  • 07332940005177 ()
GXFLU+RSV-XP-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert FLU/RSV XC kit; 10 test kit
CEPHEID
GXFLU/RSV-10
In Commercial Distribution

  • 07332940000783 ()
GXFLU/RSV-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2660
In Commercial Distribution

  • 20816101025552 ()
MOL2660

  • Multiple-genus respiratory virus nucleic acid IVD, control
No Description
DIASORIN MOLECULAR LLC
MOL2650
Not in Commercial Distribution

  • 20816101025545 ()
MOL2650

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2600
In Commercial Distribution

  • 20816101025538 ()
MOL2600

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2160
In Commercial Distribution

  • 20816101025514 ()
MOL2160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® Specimen Lysis Tubes.
Hologic, Inc.
SPECIMEN LYSIS TUBES, IVD
In Commercial Distribution

  • 15420045509238 ()
PRD-04339

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROADENO+ KIT, 100 REACTIONS
Not in Commercial Distribution

  • 15420045506381 ()
303675

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 1,500 REACTIONS
Not in Commercial Distribution

  • 15420045506343 ()
303123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 2,000 REACTIONS
Not in Commercial Distribution

  • 15420045506336 ()
303121

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PRODESSE PROFLU+ ASSAY
Not in Commercial Distribution

  • 15420045506329 ()
303111

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