The FlowFlex™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses or pathogens.
The intended use of this
test is for testing twice over two or three days with at least 24 hours and no more than 48 hours between tests.
For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
Four key features are:
1 HASSLE FREE
2 FAST RESULTS
3 SELF CONTAINED
4 FLEXIBLE
Blood Wellness panels are groups of tests that determine a patient’s general health.
A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
The Flowflex COVID-19 Antigen Home Test does not require serial testing.
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, not for any other viruses or pathogens.
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 IVDs 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.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
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Contact DïGEN LABS. DïGEN LABS is a registered medical device and pharmacuetiucal distributor in the state of Texas. We have direct relationships with manufacturers and various wholesale and reseller outlets.
DïGEN LABS
11111 Katy Freeway, 910
Houston, TX 77079
Phone: (855) 277-1276
Fax: (888) 636-7540
Email: info@digenlabs.com
DïGEN LABS Houston Sales Office
11111 Katy Freeway, 910
Houston, TX 77079
Phone: (855) 277-1276
Fax: (888) 636-7540
Email: info@digenlabs.com
DïGEN LABS is a registered medical device and pharmacuetiucal distributor in the state of Texas. We have direct relationships with manufacturers and various wholesale and reseller outlets. In addition, we have strong affiliations with high-complexity CLIA and CAP accredited laboratories that specialize in biochemistry, cytogenetics, microbiology, molecular genetics, pharmacology, and toxicology.