Trending...
- Inkdnylon Custom Apparel Launches Cost-Saving System for Promotional Products and Custom Apparel in Chicago
- Larry R. Wasion Highlights Jump Gate I: Time Chair. The Opening Novel in His Expansive Science Fiction Series
- Evolve Construction Mobilizes Commercial Storm Response Across Illinois With AI-Powered Damage Documentation and Public Adjusters Partnership
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
- Epic Pictures Group Sets North American Release Date for the Thriller NO ORDINARY HEIST
- Award-Winning REALTOR® Paige Coker Joins Corcoran DeRonja Real Estate
- Over 98% of crypto owners globally don't declare taxes, new report find
- TicTac Group acquires French EdTech company Distrisoft
- Mark Dobosz Makes Donorassess.org Free To Every Nonprofit On The Planet
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
- K4Connect Launches Team Hub 5.0 — The Intelligent Execution Layer for Senior Living
- New Book Reveals The Science Of Predictions
- Compliance Alert: Maryland, Texas Regulate Use of Artificial Intelligence in Utilization Reviews
- Colony Ridge Communities Celebrates Successful Soccer Season Kickoff with Families and Youth
- EFA Announces 2026 Editorial Rate Chart
- NYC Composer/Educator Launches Debut Children's Book to Fantastic Reviews
- Red5 Taps PubNub to Power the Next Era of Real-Time Interactive Streaming
- Yield Curve Shifts Drive Retail Traders to AI Trading for 126% Annualized Return Stability
- Shoutout Joseph Neibich aka Nybyk
- Meet Joseph Neibich aka Joseph Nybyk of Beachwood Canyon
- LARUS Launches Business Continuity Framework for IPv4-Dependent Networks
- A Cure In Sight Advances Ocular Melanoma Advocacy During Rare Disease Week 2026 in Washington, DC
- Craigory Dunn Introduces "The Craig Nice Report," A Bold Response to the AI Music Debate
- KeysCaribbean Offers 'Skip-the-Crowds' Savings With 15 Percent Off April Stays
- New from Regal House Publishing, A Reckoning Up Black Cat Hollow, a psychological crime thriller
- Supply & Demand Chain Executive Names Puga Sankara as Recipient of 2026 Pros to Know Award
- K4Connect launches K4IQ™, an intelligence layer on FusionOS turning data into actionable insights
- Atelier 4 Appoints Museum Logistics Expert Heather Haldeman as Senior Client Advisor
- AI Disruption Meets Marine Scale: Off The Hook YS, Inc. (N Y S E American: OTH) Targets Breakout Growth with NextBoat Launch and Aggressive Expansion
- Targeting the Billion-Dollar U.S. Countermeasure Market With AI-Driven Biodefense Platform: Lunai Bioworks (N A S D A Q: LNAI)