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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 RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
MESA BIOTECH, INC.
1029
In Commercial Distribution

  • B54010290 ()
1029

  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
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)
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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
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
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) 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)
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