Trending...
- BumblebeeSmart Announces Partnership with Extreme Kids World to Expand Access to Sensory Wall Panels and Educational Busy Boards
- Landmark Construction Expands Glass, Glazing, and Commercial Remodeling Services Across Los Angeles County and Surrounding Areas
- Director Sean McNamara Reunites with Award-Winning Cinematographer Shawn Seifert for Upcoming Feature Home
CHARLOTTE, N.C., Sept. 2, 2020 /PRNewswire/ -- Biohit Healthcare's antibody and antigen tests for Covid-19 have been awarded ANVISA status, the official stamp of approval from Brazil's Ministry of Health. Biohit's Sars-CoV-2 IgM/IgG antibody test and SARS-CoV-2 Antigen quantitative assay kit are now included in the select group of Covid-19 tests of allowed manufacturers of goods in Brazil.
"Our Biohits test kits had already earned FDA's coveted EUA (Emergency Use Authorization) and now this great news from Brazil. Very exciting," says Dr. James Strader, CEO Bio Testing Supplies, the pandemic division of Avrio Genetics. "
Anvisa certification is granted only to companies that have been proven to maintain good manufacturing practices for health products so Biohit's approval by ANVISA means it meets the standards of Brazilian Class III vitro diagnostic products across the board. "It adds up to a blanket approval from the Brazilian government," says Strader.
"In their selection process, Brazil started with products already on the EUA authorization list and went from there, so selecting Biohit as only one of three companies to get the ANVISA é enorme…is huge," says Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina.
More on ncarol.com
The Sars-Cov-2 Antigen test shows who has or does not have active Covid-19 while Biohit's Sars-CoV-2 IgM/IgG Antibody Test Kit, a rapid laminar flow assay (LFA) that typically delivers results within 15 minutes, identifies those who have already had the virus and have thus acquired antibodies. When evaluated by the FDA, this test was shown to have a very high IgM and IgG sensitivity as well as a very high specificity. "This is important as it shows who may have possible immunity and thus a potential green light to resume their daily life," explains Schaffer
With a population of close to 210 million—Brazil has about 2/3 the number of people in the U.S.—there is a lot of testing to be done. Biohit's ANVISA status will make it possible for these tests to play an important role in combating Covid-19 in this country.
"Fortunately we have several million Biohit test kits in the pipeline ready to be shipped by Bio Testing Supplies, a 'go to' company that also sells other diagnostic testing supplies including personal protective equipment (PPE)," adds Dr. Strader.
For more information and to order the Biohit test kit contact: biotestingsupplies.com
Media contact: [email protected]
SOURCE Bio Testing Supplies
"Our Biohits test kits had already earned FDA's coveted EUA (Emergency Use Authorization) and now this great news from Brazil. Very exciting," says Dr. James Strader, CEO Bio Testing Supplies, the pandemic division of Avrio Genetics. "
Anvisa certification is granted only to companies that have been proven to maintain good manufacturing practices for health products so Biohit's approval by ANVISA means it meets the standards of Brazilian Class III vitro diagnostic products across the board. "It adds up to a blanket approval from the Brazilian government," says Strader.
"In their selection process, Brazil started with products already on the EUA authorization list and went from there, so selecting Biohit as only one of three companies to get the ANVISA é enorme…is huge," says Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina.
More on ncarol.com
- T. Jones Group Celebrates Two Wins and Multiple Project Nominations at the 2026 HAVAN Awards
- Studica Robotics Supports Robotics Training Camp for WorldSkills Shanghai 2026
- Lineus Medical Renews Agreement with Vizient, Delivering Enhanced Value for Vizient Members
- Qscription Technologies Appoints Radiology Industry Veteran Elliot Silverman to Advisory Board
- Search Is Broken. Curated Discovery Is the Future
The Sars-Cov-2 Antigen test shows who has or does not have active Covid-19 while Biohit's Sars-CoV-2 IgM/IgG Antibody Test Kit, a rapid laminar flow assay (LFA) that typically delivers results within 15 minutes, identifies those who have already had the virus and have thus acquired antibodies. When evaluated by the FDA, this test was shown to have a very high IgM and IgG sensitivity as well as a very high specificity. "This is important as it shows who may have possible immunity and thus a potential green light to resume their daily life," explains Schaffer
With a population of close to 210 million—Brazil has about 2/3 the number of people in the U.S.—there is a lot of testing to be done. Biohit's ANVISA status will make it possible for these tests to play an important role in combating Covid-19 in this country.
"Fortunately we have several million Biohit test kits in the pipeline ready to be shipped by Bio Testing Supplies, a 'go to' company that also sells other diagnostic testing supplies including personal protective equipment (PPE)," adds Dr. Strader.
For more information and to order the Biohit test kit contact: biotestingsupplies.com
Media contact: [email protected]
SOURCE Bio Testing Supplies
Filed Under: Business
0 Comments
Latest on ncarol.com
- The KettleBelle Achieves Explosive 400% Member Growth in Four Months, Launches 5-Day Kickstart
- Soma and Sage Bringing Functional Mobility and Nervous System Regulation to Burlington NC
- Able Rooter Expands Services to Offer Premium Water Heater Installation Across St. Louis
- Director Sean McNamara Reunites with Award-Winning Cinematographer Shawn Seifert for Upcoming Feature Home
- J. Kenton Pierce Wins Prometheus Award for Best Novel
- Class is in session: Black Beauty Block Party returns to Los Angeles for fourth annual festival
- Heavy Duty Journal Surpasses 1000 Technical Articles for Diesel Technicians and Fleet Managers
- Kolbus Introduces the Next Step in Casemaking Efficiency
- Florida Law Advisers, P.A. Named Best Divorce Firm of 2026 by Expert Law Attorneys
- Sounds of LA County: 27 Parks.108 Concerts. One County
- Only One Flight Stands Between Los Angeles Youth Leaders and a Life-Saving Mission in South Africa
- BumblebeeSmart Announces Partnership with Extreme Kids World to Expand Access to Sensory Wall Panels and Educational Busy Boards
- Stigma Across Borders: Concerns Grow Over Discrimination Against Shincheonji Members Abroad
- World Cup Crowds Are a Stress Test for America's Restrooms
- Postmortem Pathology Expands Access to Private Autopsy Services in Las Vegas
- How Sacramento Families Are Using Private Autopsies to Protect Inheritances, Resolve Insurance Claims, and Find Closure
- Los Angeles' Best Food: Food Journal Magazine Examines the Trends Shaping the City's Dining Scene
- Landmark Construction Expands Glass, Glazing, and Commercial Remodeling Services Across Los Angeles County and Surrounding Areas
- ENTOUCH Named Top 100 Inspiring Workplaces in North America for Third Consecutive Year
- Pulse Wave is where moments become movements