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Text
assays for
SARS-COV-2 TEST
60061-7 (2021-01) Accula SARS-CoV-2 IFU 3 process positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. TEST COMPLETE READ RESULTS 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT CORONAVIRUS SHEET FOR PATIENTS • Where can I go for updates and more information? The most up -to date information on COVID-19 https://www.cdc.gov/is available at the CDC General webpage: COVID19 60060 REV 3 ACCULA SARS-COV-2 QRG 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
NASAL SAMPLE SELF-COLLECTION GUIDE IVD SARS-CoV-2 Quick Reference Guide EUA Only FOR NASAL SWAB SPECIMENS COV4100 1 Label SARS-CoV-2 Buffer with your name and date. SARS-CoV-2 Buffer Jane Doe March 20, 2020 FACT SHEET FOR PATIENTS This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test ACCULA™ DOCK OPERATOR’S GUIDE 3 VI. Warnings and Precautions Y Do not block the air vents located on the rear and sides of the Accula™ Dock.A minimum of 2 inches (5 cm) of clearance must be maintained. Y Do not place the Accula™ Dock in the vicinity of equipment that generates heat.The Dock must be maintained in an ambient temperature range of 15°C to 30°C (59 to86°F) to
FACT SHEET FOR HEALTHCARE PROVIDERS Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts ACTIONABLE. ACCESSIBLE. AFFORDABLE. SARS-COV-2 (COVID-19SARS-COV-2ABOUT US The Accula System has received FDA Emergency Use Authorization (EUA) for SARS-CoV-2 (the virus responsible for COVID-19) in vitro diagnostic testing. It is available now for use in patient care settings. Easy and fast, our qualitative, rapid PCR-based test provides visual results within ~ 30 minutes. The Accula SARS-CoV-2 Test has not been FDA ABOUT US - MESA BIOTECH Dr. Hong Cai co-founded the business in 2009. She has more than 20 years of experience in the field of molecular biology and is the inventor of the technology used in Mesa Biotech’s platform. She spent 13 years as a principal investigator at Los Alamos National Laboratory, managing and leading projects for nucleic acid-basedassays for
SARS-COV-2 TEST
60061-7 (2021-01) Accula SARS-CoV-2 IFU 3 process positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. TEST COMPLETE READ RESULTS 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT CORONAVIRUS SHEET FOR PATIENTS • Where can I go for updates and more information? The most up -to date information on COVID-19 https://www.cdc.gov/is available at the CDC General webpage: COVID19 60060 REV 3 ACCULA SARS-COV-2 QRG 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
NASAL SAMPLE SELF-COLLECTION GUIDE IVD SARS-CoV-2 Quick Reference Guide EUA Only FOR NASAL SWAB SPECIMENS COV4100 1 Label SARS-CoV-2 Buffer with your name and date. SARS-CoV-2 Buffer Jane Doe March 20, 2020 FACT SHEET FOR PATIENTS This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test ACCULA™ DOCK OPERATOR’S GUIDE 3 VI. Warnings and Precautions Y Do not block the air vents located on the rear and sides of the Accula™ Dock.A minimum of 2 inches (5 cm) of clearance must be maintained. Y Do not place the Accula™ Dock in the vicinity of equipment that generates heat.The Dock must be maintained in an ambient temperature range of 15°C to 30°C (59 to86°F) to
FACT SHEET FOR HEALTHCARE PROVIDERS Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scriptsSARS-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-2SARS-COV-2 TEST
4 • Store reagents at room temperature (15°C - 30°C, 59°F - 86°F). Do not refrigerate or freeze. • o not reuse kit contents Collection Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, orSARS-CoV-2
FACT CORONAVIRUS SHEET FOR PATIENTS • Where can I go for updates and more information? The most up -to date information on COVID-19 https://www.cdc.gov/is available at the CDC General webpage: COVID19 MESA BIOTECH RECEIVES EMERGENCY USE AUTHORIZATION FROM FDA Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately SAN DIEGO, CA – March 24, 2020 – Today, Mesa Biotech announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its Accula™ SARS-CoV-2Test, which gives
SARS-COV-2 BUFFER
NOTE: LOOK CLOSELY WHEN INTERPRETING THE RESULTS!The appearance of any shade of a Blue Test Line at the T position is a valid result that is interpreted as a positive for SARS-CoV-2 viral RNA. A negative result will only contain a Blue MESA BIOTECH ANNOUNCES INGO CHAKRAVARTY AS PRESIDENT AND SAN DIEGO, CA – April 15, 2020 – The Board of Directors of Mesa Biotech, announced today the appointment of Ingo Chakravarty as President and Chief Executive Officer (CEO), effective immediately.. Mr. Chakravarty succeeds Dr. Hong Cai, Co-Founder and CEO of Mesa Biotech since 2010. Dr. Cai will remain actively involved with the company in her new role as Chief Technology Officer. IT IS PCR IN THE PALM OF YOUR HAND. It is PCR in the palm of your hand. Accurate, Accessible, Actionable diagnosis for better healthcare Influenza A/B & Respiratory SyncytialVirus (RSV)
SEKISUI DIAGNOSTICS ENTERS STRATEGIC ALLIANCE WITH MESA Sekisui Diagnostics becomes exclusive distributor for Mesa Biotech products in the U.S. and Canada Strategic alliance expands Sekisui Diagnostics’ portfolio and facilitates entry into the molecular point-of-care (POC) market starting with Flu A/Flu B test (pending FDA clearance) followed by additional upper respiratory infectious disease assays Mesa Biotech products will have immediate MESA BIOTECH TO INTRODUCE EXPANDED MOLECULAR POC TESTING SAN DIEGO, CA – April 9, 2019 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its expanded, novel Accula™ Test System at the 29th Annual European MESA BIOTECH ANNOUNCES KEY ADDITIONS TO EXECUTIVE SAN DIEGO, May 17, 2016 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed a testing platform designed specifically for point-of-care infectious disease diagnosis, today announced the appointment of Tom Willardson as Chief Financial Officer and John Monroe as Senior Vice President of Operations. “We are delighted to have Tom and John ACTIONABLE. ACCESSIBLE. AFFORDABLE. SARS-COV-2 (COVID-19SARS-COV-2ABOUT US Mesa Biotech is a healthcare test and data company that provides actionable information through trusted, PCR-based infectious diseasetesting.
ABOUT US - MESA BIOTECH Pete Bantock is a seasoned executive with international commercial and general management experience. With a colorful career that spans clinical diagnostics, biotechnology and pharmaceuticals, he brings an eclectic perspective to commercializing and operationalizing technologies in a variety of healthcare delivery settings.SARS-COV-2 TEST
60061-7 (2021-01) Accula SARS-CoV-2 IFU 3 process positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay.SARS-COV-2 TEST
4 • Store reagents at room temperature (15°C - 30°C, 59°F - 86°F). Do not refrigerate or freeze. • o not reuse kit contents Collection Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, orSARS-CoV-2
TEST COMPLETE READ RESULTS 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT CORONAVIRUS SHEET FOR PATIENTS • Where can I go for updates and more information? The most up -to date information on COVID-19 https://www.cdc.gov/is available at the CDC General webpage: COVID19 60060 REV 3 ACCULA SARS-COV-2 QRG 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT SHEET FOR PATIENTS This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test ACCULA™ DOCK OPERATOR’S GUIDE 3 VI. Warnings and Precautions Y Do not block the air vents located on the rear and sides of the Accula™ Dock.A minimum of 2 inches (5 cm) of clearance must be maintained. Y Do not place the Accula™ Dock in the vicinity of equipment that generates heat.The Dock must be maintained in an ambient temperature range of 15°C to 30°C (59 to86°F) to
WILLIAM R. BRODY JOINS MESA BIOTECH AS CHAIRMAN OF THE SAN DIEGO, April 6, 2016 – Mesa Biotech Inc., a privately-held, molecular diagnostic company developing a testing platform designed specifically for point-of-care infectious disease diagnosis, today announced that William R. Brody, M.D., Ph.D. has been appointed Mesa Biotech’s Chairman of the Board. As former president of San Diego’s Salk Institute for Biological Studies, Brody ACTIONABLE. ACCESSIBLE. AFFORDABLE. SARS-COV-2 (COVID-19SARS-COV-2ABOUT US Mesa Biotech is a healthcare test and data company that provides actionable information through trusted, PCR-based infectious diseasetesting.
ABOUT US - MESA BIOTECH Pete Bantock is a seasoned executive with international commercial and general management experience. With a colorful career that spans clinical diagnostics, biotechnology and pharmaceuticals, he brings an eclectic perspective to commercializing and operationalizing technologies in a variety of healthcare delivery settings.SARS-COV-2 TEST
60061-7 (2021-01) Accula SARS-CoV-2 IFU 3 process positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay.SARS-COV-2 TEST
4 • Store reagents at room temperature (15°C - 30°C, 59°F - 86°F). Do not refrigerate or freeze. • o not reuse kit contents Collection Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, orSARS-CoV-2
TEST COMPLETE READ RESULTS 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT CORONAVIRUS SHEET FOR PATIENTS • Where can I go for updates and more information? The most up -to date information on COVID-19 https://www.cdc.gov/is available at the CDC General webpage: COVID19 60060 REV 3 ACCULA SARS-COV-2 QRG 60060-3 (2020-07) Mesa Biotech, INC. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121, USA www.mesabiotech.com D. INTERPRETATION OFRESULTS
FACT SHEET FOR PATIENTS This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test ACCULA™ DOCK OPERATOR’S GUIDE 3 VI. Warnings and Precautions Y Do not block the air vents located on the rear and sides of the Accula™ Dock.A minimum of 2 inches (5 cm) of clearance must be maintained. Y Do not place the Accula™ Dock in the vicinity of equipment that generates heat.The Dock must be maintained in an ambient temperature range of 15°C to 30°C (59 to86°F) to
WILLIAM R. BRODY JOINS MESA BIOTECH AS CHAIRMAN OF THE SAN DIEGO, April 6, 2016 – Mesa Biotech Inc., a privately-held, molecular diagnostic company developing a testing platform designed specifically for point-of-care infectious disease diagnosis, today announced that William R. Brody, M.D., Ph.D. has been appointed Mesa Biotech’s Chairman of the Board. As former president of San Diego’s Salk Institute for Biological Studies, BrodySARS-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 FACT SHEET FOR PATIENTS This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test MESA BIOTECH TO RECEIVE FUNDING FROM US HEALTH AND HUMAN Since its inception at Los Alamos National Lab, Mesa Biotech has focused on technology well-suited for emergency defense, near-patient testing and rapid response to pandemics, such as SARS, Ebola and now COVID-19 SAN DIEGO, CA – March 19, 2020 – Mesa Biotech Inc., a privately-held, molecular diagnostic company has developed an affordable, 30 minute sample-to-answer NASAL SAMPLE SELF-COLLECTION GUIDE IVD SARS-CoV-2 Quick Reference Guide EUA Only FOR NASAL SWAB SPECIMENS COV4100 1 Label SARS-CoV-2 Buffer with your name and date. SARS-CoV-2 Buffer Jane Doe March 20, 2020HCP FACT SHEET
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scriptsSARS-COV-2 BUFFER
NOTE: LOOK CLOSELY WHEN INTERPRETING THE RESULTS!The appearance of any shade of a Blue Test Line at the T position is a valid result that is interpreted as a positive for SARS-CoV-2 viral RNA. A negative result will only contain a Blue IT IS PCR IN THE PALM OF YOUR HAND. It is PCR in the palm of your hand. Accurate, Accessible, Actionable diagnosis for better healthcare Influenza A/B & Respiratory SyncytialVirus (RSV)
MESA BIOTECH TO INTRODUCE EXPANDED MOLECULAR POC TESTING SAN DIEGO, CA – April 9, 2019 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its expanded, novel Accula™ Test System at the 29th Annual European FACT SHEET FOR HEALTHCARE PROVIDERS Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts MESA BIOTECH TO DEMONSTRATE NEW MOLECULAR POC TESTING SAN DIEGO – April 18, 2018 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its novel Accula™ Flu A/Flu B test at the 28th Annual European Congress of Clinical MicrobiologyNo results found.
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Accurate. Accessible. Actionable. Simplifying PCR, transforming healthcare.Our Technology
Accurate. Accessible. Actionable. Simplifying PCR, transforming healthcare.Our Product
Accurate. Accessible. Actionable. Simplifying PCR, transforming healthcare.About Mesa Biotech
POINT-OF-CARE MOLECULAR SYSTEM _LET US SHOW YOU SOMETHING YOU’VE NEVER SEEN BEFORE…_Our Technology
\n","url":"https://www.youtube.com/watch?v=GZzHt-mdDCI","width":854,"height":480,"providerName":"YouTube","thumbnailUrl":"https://i.ytimg.com/vi/GZzHt-mdDCI/hqdefault.jpg","resolvedBy":"youtube"}" data-block-type="32" id="block-yui_3_17_2_1_1564077216537_17300"> " data-provider-name="YouTube" id="yui_3_17_2_1_1572883575026_113"> -------------------------COLLECT
SIMPLE NASAL SWAB SPECIMEN COLLECTION.LOAD & RUN
DISPENSE THE BUFFER INTO THE CASSETTE, CLOSE THE DOCK LID AND WALKAWAY.
READ
WHEN NOTIFIED BY THE DOCK, REMOVE THE CASSETTE AND READ THE TESTRESULTS.
Our Product
------------------------- THE KEY TO OUR SUCCESS IS OUR TEAM OF DEDICATED AND TALENTED EMPLOYEES, EMPLOYEES THAT ARE DRIVEN TO DELIVER NOVEL, QUALITY DIAGNOSTIC PRODUCTS.Our Company
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