Address:9440 Carroll Park Drive,San Diego,CA,92121,US
Device Description : The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use i The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris Dock is an electronic module which executes in vitro diagnostic test The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality c The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro dia The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors.
Device Class :
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro dia The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors.
Device Class : 2
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock i The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
Device Class :
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula™ SARS-CoV-2 Test. Positive swabs are coated with DNA Based Synthetic Oligo. The High Positive Controls contain a level of oligo sufficient to provide a positive result when used with the Accula SARS-CoV-2 Test. The Low Positive Controls contain a lower level of oligo, near the limit of detection of the test, but is sufficient to provide a positive result when used with the Accula™ SARS-CoV-2 Test. When used for quality control in the Accula SARS-CoV-2 Test, these controls are useful as an aid in verifying test and operator performance.
Device Class :
Duns Number: 056865474
Premarket Exempt : No
Prescription Use : Yes