Trending...
- Opteamix welcomes Girish Ramachandra to its leadership team as Senior Vice President of Client Services
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
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
- Crownlight Strategies® Announces Federal Trademark Registration
- New Book Calls 'Sense of Belonging' the Missing Link in Student Success
- Igbozue Connecticut USA Celebrates 2026 Summer Family Picnic
- KT Medical Staffing Addresses the Questions Families Forget to Ask Before Bringing Private Nursing Care Home
- Private Autopsies Give Arizona Families Answers After Nursing Home and Care Facility Deaths
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
- Bent Danholm's The Architecture of Demand Reaches No. 2 in Amazon Real Estate Sales
- Contracting Resources Group Named to Inc. 5000 for the Ninth Time
- ImagineX Named to 2026 Inc. 5000 List of America's Fastest-Growing Private Companies
- ASSIST Software Becomes One of the First European Companies Certified to ISO/IEC 42001
- The World's No.1 Superstar® Enters the Occult with New Track and Cinematic Visual "Under Your Spell"
- PricZone Launches Online Shopping Platform Offering Electronics, Gaming, and More
- Heritage at South Brunswick Introduces New Ferndale Floorplan: The Largest Single-Family Home Design in the Community
- Lineus Medical Elevates Leadership to Accelerate Growth After Breakthrough Clinical Results
- Gateway Center Arena Announces Duane Curry as General Manger
- New from Regal House Publishing, The Parliament of Mice, classic animal fables retold as satires
- XRPPower Expands Platform Security With Enhanced Brand Protection and Official Verification Standards
- Cuvo Health, the #1 White Label Telehealth Platform, Surpasses 300 Exclusive Providers Serving All 50 States
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- International Rights Groups Raise Alarm Over Freedom of Religion and Expression in South Korea
- The City's Most Elegant Open-Air Dinner Party Returns September 12, 2026
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
- Autonomous Robotics Platform Expansion as Public Market Debut is Very Close: MBody AI Corp. (N A S D A Q: MBAI)
- New Book gives Consumer Goods Leaders a Governance Playbook for Generative and Agentic AI
- Loud! OOH calls for prize draw advertising standards as £1.3bn category moves outdoors