mesabiotech.com
sekisuidiagnostics.comAccula Strep A Test
Mesa Biotech, Inc.
MESA BIOTECH, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013026082 | 3013026082 | MESA BIOTECH, INC | 1 | N | 2020-04-25 | 6190 Cornerstone Court E Suite220 San Diego CA US 92121 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B54010240 | Silaris Influenza A&B Control Kit - The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test. | 781.652.7800 | sdadiagnosticstsdl@sekisuidiag |
| B54010240 | Silaris Influenza A&B Control Kit - The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test. | 781.652.7800 | sdadiagnosticstsdl@sekisuidiagnostics.com |
| B54010280 | SilarisTM Influenza A&B Starter Pack - 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. | 781.652.7800 | sdadiagnosticstsdl@sekisuidiag |
| B54010280 | SilarisTM Influenza A&B Starter Pack - 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. | 781.652.7800 | sdadiagnosticstsdl@sekisuidiagnostics.com |
| B540COV4100010 | Accula SARS CoV-2 Control Kit - 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. | 858-800-4929 | info@mesabiotech.com |
| B540D20000 | Accula Dock - 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. | 858-800-4929 | info@mesabiotech.com |
| B540D20010 | Accula Programming Cassette - 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 | 858-800-4929 | info@mesabiotech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216396 | 1558743013 | K181443 | Accula RSV Test | OCC | 2018-11-23 |
| 216396 | 1234383645 | K171641 | Accula Flu A/Flu B Test | OZE | 2018-02-06 |
| 216396 | 1528090184 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Accula Flu A / B Control Kit - The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test.
2022-10-17
Accula Programming Cassette - 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
2020-06-08
Accula Dock - 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.
2020-04-13
Silaris Influenza A&B Control Kit - The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test.
2018-03-15
Silaris Dock - 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.
2018-03-15
SilarisTM Influenza A&B Starter Pack - 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.
2018-03-15
Accula Flu A / B Test - 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.
2022-10-17
Accula SARS CoV-2 Control Kit - 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.
2020-05-19
Accula SARS-CoV-2 Test - 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.
2020-04-13
Silaris RSV Supplemental Pack - 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.
2019-07-29
Silaris RSV Control Kit - The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
2019-07-29
Silaris RSV Test - 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.
2019-07-29
Sialris Influenza A&B Supplemental Pack - 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.
2019-07-29
Silaris Influenza A&B Test - 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.
2018-03-15