DERMACARE BIOSCIENCES TO DISTRIBUTE ACON LABS NEW FLOWFLEX PLUS COVID-19 and FLU A/B HOME TEST PER AN FDA EUA
We are pleased to be working closely with ACON LABS.”
— Rich Butler, Dermacare Biosciences Partner, Co-Founder
DELRAY BEACH, FL, UNITED STATES, August 27, 2024 /EINPresswire.com/ — Dermacare Biosciences, a South Florida based healthcare distribution company is pleased to announce that they will distribute the new FLOWFLEX PLUS COVID-19 and FLU A/B home test per an FDA EUA issued to ACON LABS in July 2024.
Dermacare Biosciences Managing Director Rich Butler said, “This test is authorized for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.”
Butler points out, “This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.”
“The FLOWFLEX PLUS at home test offers critical information when & where it’s needed”, said Butler, “The Flowflex® COVID-19 Antigen Home Test is all you need to determine your family’s Covid-19 status, whether symptoms are present or not. It can be used on children as young as 2 years old. It’s an affordable Easy-to-Use Nasal Swab Test, Results in 15 minutes, Safe for children as young as 2 years old, for use with and without symptoms”. “We are pleased to be working closely with ACON LABS and making these important self-tests available at the best prices possible for businesses and companies”
The FLOWFLEX PLUS COVID-19 and FLU A/B Home Test is expected to be available around the end of August 2024 to early September, just in time for the Fall and Winter Flu season. Businesses and retailers are encouraged to place orders now to avoid potentially longer waits once the busy Fall /Winter FLU season arrives.
ABOUT DERMACARE BIOSCIENCES
Dermacare Biosciences is a wholly owned division of Dermacare Packaging & Private Label, LLC, based in South Florida.
We are Manufacturers, Importers & Distributors of Medical Testing Devices, Healthcare Supplies, Hand Sanitizers, Private Label Personal Care, Biodradable Nitrile Gloves, and Women’s Reproductive Health OTC products.
Contact us at: info@dermacarebio.com
Kelly Stone, Chief Sales Officer: kelly@dermacarepkg.com
Rich Butler, Managing Director: rich@dermacarebio.com
Russ Rossi, National Sales Director: russ@dermacarebio.com
Rich Butler
Dermacare BioSciences
+1 561-818-9105
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