FDA authorized under EUA iHealth Covid-19 Rapid Antigen Home Test Kit
Rapid test, results are read at fifteen minutes
Home test kit, two tests per box
Anterior nasal swab specimen collection
Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow
FDA authorized under EUA Flowflex Covid-19 Rapid Antigen Home Test Kit
Rapid test, results are read at fifteen minutes
Home test kit, one tests per box
Anterior nasal swab specimen collection
Clinical Sensitivity 93%, Specificity 100%
Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow
AMPER COVID-19 Antigen Rapid Testing Kit
CE Marked, FDA EUA submitted
No lab equipment or additional instrument required
Nasopharyngeal swab specimen collection
Detects SARS-CoV-2 nucleocapsid protein antigen
via a lateral flow assay
FDA authorized under EUA AccessBio CareStart Covid-19 Rapid Antigen Home Test Kit
Rapid test, results are read at ten minutes
Home test kit, two tests per box
Anterior nasal swab specimen collection
Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow
FDA authorized under EUA AccessBio Covid-19 Rapid Antigen Test Kit
Rapid test, results are read AT ten minutes
Nasopharyngeal swab specimen collection
Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow
This test is only approved in a POC setting and that users must have a CLIA certificate of waiver
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of proteins from SARS-CoV-2, 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
FDA EUA Abbott's BinaxNOW COVID-19 Rapid Antigen Test Card
First at-home, virtually guided service
15-minute antigen test
No instrument need
FDA Emergency Authorization Letter
Contact Information:
Mail: NeoGeneStar LLC
100 Randolph Road, Suite 2B
Somerset, NJ 08873
USA
Phones: (732) 421-4567
Fax: (908) 756-4483
Email: NeoGeneStar@gmail.com
General: Info@NeoGeneStar.com
Technical support: Tech@NeoGeneStar.com
Business Development: BD@NeoGeneStar.com
Place orders: Order@NeoGeneStar.com