Other products from "MESA BIOTECH, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B54010270 1027 1027 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Silaris Influenza A&B Test
2 B540D20010 D2001 D2001 The Programming Cassette is an accessory to the Accula Dock and facilitates repr The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware QJR,OZE,OCC Reagents, 2019-Novel Coronavirus Nucleic Acid,Influenza A And Influenza B Multip Reagents, 2019-Novel Coronavirus Nucleic Acid,Influenza A And Influenza B Multiplex Nucleic Acid Assay,Respiratory Virus Panel Nucleic Acid Assay System 2 Accula Programming Cassette
3 B540COV41000 COV4100 COV4100 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. QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Accula SARS-CoV-2 Test
4 B540FAB1100CWC0 FAB1100CW-C FAB1100CW-1 The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qua The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Accula Flu A / B Control Kit
5 B540D20000 D2000 D2000 The Accula Dock is an electronic module which executes in vitro diagnostic tests The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible 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. QJR,OZE,OCC Reagents, 2019-Novel Coronavirus Nucleic Acid,Influenza A And Influenza B Multip Reagents, 2019-Novel Coronavirus Nucleic Acid,Influenza A And Influenza B Multiplex Nucleic Acid Assay,Respiratory Virus Panel Nucleic Acid Assay System 2 Accula Dock
6 B540FAB1100CW0 FAB1100CW FAB1100CW The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro The Accula™ Flu A / B Test performed on the Accula 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 Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Accula Flu A / B Test
7 B54010300 1030 1030 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. Silaris RSV Test
8 B540COV4100010 COV4100-1 COV4100-1 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. Accula SARS CoV-2 Control Kit
9 B54010350 1035 1035 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Sialris Influenza A&B Supplemental Pack
10 B54010280 1028 1028 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. OZE,OCC Influenza A And Influenza B Multiplex Nucleic Acid Assay,Respiratory Virus Panel Influenza A And Influenza B Multiplex Nucleic Acid Assay,Respiratory Virus Panel Nucleic Acid Assay System 2 SilarisTM Influenza A&B Starter Pack
11 B54010260 1026 1026 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. OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay 2 Silaris Dock
12 B54010400 1040 1040 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Silaris RSV Supplemental Pack
13 B54010240 1024 1024 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Silaris Influenza A&B Control Kit
Other products with the same Product Code "OCC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B540FAB1100CWC0 FAB1100CW-C FAB1100CW-1 The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qua The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test. Accula Flu A / B Control Kit MESA BIOTECH, INC.
2 B540FAB1100CW0 FAB1100CW FAB1100CW The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro The Accula™ Flu A / B Test performed on the Accula 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 Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu 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. Accula Flu A / B Test MESA BIOTECH, INC.
3 B540D20010 D2001 D2001 The Programming Cassette is an accessory to the Accula Dock and facilitates repr The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware Accula Programming Cassette MESA BIOTECH, INC.
4 B540D20000 D2000 D2000 The Accula Dock is an electronic module which executes in vitro diagnostic tests The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible 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. Accula Dock MESA BIOTECH, INC.
5 B54010400 1040 1040 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. Silaris RSV Supplemental Pack MESA BIOTECH, INC.
6 B54010350 1035 1035 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. Sialris Influenza A&B Supplemental Pack MESA BIOTECH, INC.
7 B54010290 1029 1029 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 Silaris RSV Control Kit MESA BIOTECH, INC.
8 B54010280 1028 1028 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. SilarisTM Influenza A&B Starter Pack MESA BIOTECH, INC.
9 B54010270 1027 1027 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. Silaris Influenza A&B Test MESA BIOTECH, INC.
10 B54010240 1024 1024 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. Silaris Influenza A&B Control Kit MESA BIOTECH, INC.
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19 15420045509320 AMR CTRLS, PANTHER FUSION, IVD PRD-04338 PANTHER FUSION HOLOGIC, INC.
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28 15420045509214 EXTRACTION REAGENT-S, 960T, IVD PRD-04331 PANTHER FUSION HOLOGIC, INC.
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