Trending...
- Psychiatric Hospitals Fail to Warn Electroshock Patients of FDA-Cited Risks in Estimated $7 Billion Industry
- This Weekend Causeway Cove Country BBQ & Music Festival Returns for Fourth Year, Celebrating America's 250th Anniversary on the Water
- Nayarit Strengthens Its Position as a Global Surf Destination; Sayulita to Become Mexico's First Official Surf City
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
- Marketing Company Helps Local Businesses Stop Renting Leads and Start Building A Permanent System
- Verbica Challenges Panetta to a Televised Debate on the Issues
- Salt Lake City Families Turn to Private Autopsy Services for Faster Answers After Unexpected Loss
- K2 Integrity's U.S. and EMEA Teams Again Recognized in Chambers and Partners 2026 Guides
- Connecta Satellite Solutions Ready to Support Emergency Communications Following the Venezuela Earthquake
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
- Leicester UK Manufacturer Tabletop Tyrant Secures Flawless 100% Customer Satisfaction Rating Across 5,800+ Orders
- The Calida Group Announces Promotion of Joshua Nelson to President, Advancing Next Phase of National Growth
- Cango Mobility x Hikvision Announce Strategic Partnership
- HomeCentris Healthcare Signs Definitive Agreement to Acquire S&K Holdings, Expanding Mid Atlantic Platform
- Nayarit Strengthens Its Position as a Global Surf Destination; Sayulita to Become Mexico's First Official Surf City
- Custom Cushions and Sewing Solutions Available in Cleveland County and Surrounding Areas
- Century Fasteners de Mexico Exhibiting at 2026 Farnborough International Airshow
- George Martinez Completes Community Re-distribution Initiative, Returning $5,000 In Campaign Resources To Anchorage Nonprofits
- Mister Omaha Tries The Turf At Lone Star Park
- Andrew D. Levine Releases The Lily Network, an Indian Noir Mystery of Power, Paperwork & Murder
- The Mapping Software Behind America's Viral Maps Just Got Faster and Smarter
- Longevityresearch.ca publishes cross-disease causal analysis quantifying endpoint reduction across 27 diseases
- LEAN Culture Advisor Launches to Help Organizations Build High‑Performance, LEAN Workplace
- Joulescope JS320 Launches to Help Engineers Develop Battery-Powered Devices with Greater Confidence
- Ghanaian Afrobeat Artist Praise Kusi Announces Upcoming EP "After 21:00" Releasing July 3, 2026
- TURRENTINE: A Family Legacy United Through Music
- Save 10 Percent Off Summer Stays at KeysCaribbean Resorts
- Apple Rock Named to Event Marketer's 2026 Fab 50 for Fourth Consecutive Year
- CGI Announces Pre-Order Launch for New Integrated Behavioral Health Book
- Angelina Bianchino Launches Hometown Realtor Initiative to Expand Homeownership Opportunities