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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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
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-THC-FEN-MDMA-OXY-PCP
Mlife Diagnostics, LLC
MV002.09.0001EI
In Commercial Distribution

  • G474MV002090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MV002.06.0001EI
In Commercial Distribution

  • G474MV002060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MV001.10.0003EI
In Commercial Distribution

  • G474MV001100003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-6MAM-MDMA-OXY
Mlife Diagnostics, LLC
MV001.09.0003EI
In Commercial Distribution

  • G474MV001090003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-THC
Mlife Diagnostics, LLC
MV001.09.0002-EI
In Commercial Distribution

  • G474MV001090002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MDMA-THC-MET-OPI-OXY-PCP-FEN
Mlife Diagnostics, LLC
MV001.09.0001-EI
In Commercial Distribution

  • G474MV001090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 8 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-MDMA-OXY
Mlife Diagnostics, LLC
MV001.08.0001EI
In Commercial Distribution

  • G474MV001080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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