The CareStart™ COVID-19 rapid antigen HOME Kit is a perfect solution for testing large groups or individuals, without needing a CLIA Waiver or medical professional to administer. They are quick, affordable and easy to use. Ideal for testing employees, fans, students, faculty, athletes, family members and more
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
1 HASSLE FREE
2 FAST RESULTS
3 SELF CONTAINED
4 FLEXIBLE
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 CareStart™ 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
Contact DïGEN LABS today to see how we can help meet your testing and medical equipment needs.
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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.