Trending...
- Sexually Abused in a Psychiatric Hospital or Psychiatrist's or Psychologist's Office? CCHR Urges Survivors to Reach Out to It
- Healthcare Leaders Publish New Integrated Behavioral Healthcare Guide, Led by Doctors of Behavioral Health
- Connecta Satellite Solutions Ready to Support Emergency Communications Following the Venezuela Earthquake
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
- OneVizion Names AI Leader Matthew Kirk as Chief Operating Officer to Drive Governed AI Across Telecom and Electric Utilities
- Dentists launch independent platform to help practices choose the right technology
- Contracting Resources Group Recognized by The Daily Record as a 2026 In the Lead: Best Women-Owned Businesses Honoree
- Woodforest Acceptance Solutions and AlpacaBOSS Launch Partnership
- New "Lakeside Picnic Ride" Package in Japan's Lake Chuzenji region of Nikko: July 1- November 30, 2026
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
- Data Tiles Introduces the Decision-Driven Enterprise to North America
- FitTrace Sync 1.11 Brings Apple Health and Google Health Connect Integration Into Its Mobile App
- Disruptor Creations Pioneers New MicroAdventure Series with TravelSpike
- eCopier Solutions Surpasses 3,000 Five-Star Google Reviews and Maintains Perfect Five-Star Rating
- Creative Investment Research Welcomes Supreme Court Decision Protecting Federal Reserve Independence While Calling for Continued Accountability
- New from Regal House Publishing, The Reel Life of Zara Kegg: Love, grief, Godzilla, odd beach winter
- Ascent Solar Technologies (N A S D A Q: ASTI): Positioned at the Intersection of the New Space Economy, Defense Innovation and Next-Generation Energy
- Triple-Digit Growth, Stock Market Upgrade plus a Rapidly Expanding Specialty Healthcare Platform: Cardiff Lexington Corporation (Stock Symbol: CDIX)
- Morrisville & Cary Education Centers Honored with National Award
- AI-Powered Neuropsychiatry, FDA Regulatory Momentum, Commercial Ketamine Launch Position NRx Pharmaceuticals for Potential Breakout Growth in 2026
- Henri-Lloyd Launches Sail Free to Break Down Barriers to Sailing
- Genuine Hospitality, LLC Selected to Operate Hilton Garden Inn Jacksonville JTB/Deerwood Park
- Destination Niagara Launches Game Changing Digital Magazine Redefining How Visitors Experience Niagara Falls
- Join us at Seaside Art Gallery for our July 4th celebration
- San Diego's newest marketing firm is boring on purpose — it's working
- Arizona Christian Homeschools Launches Statewide Directory
- Sexually Abused in a Psychiatric Hospital or Psychiatrist's or Psychologist's Office? CCHR Urges Survivors to Reach Out to It
- Senco Home Services Expands Residential Construction Services
- Ricci's Painting & Contracting Expands Home Transformation Services
- CFP, Trauma of Money Specialist Shannah Game Launches YouTube Show Built Around Baking and the Emo