COVID-19 Antigen Test
COVID-19 Antigen Test
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
AMPER COVID-19 Antigen Rapid Testing Introduction
FDA EUA submission letter
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 Home Test Kit IFU
Accessbio CareStart Covid Rapid Antigen Home Test Kit Introduction
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
FDA authorized under EUA AccessBio Covid-19 Rapid Antigen Test Kit IFU
- 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
Mail: NeoGeneStar LLC
100 Randolph Road, Suite 2B
Somerset, NJ 08873 USA
Phone: (732) 421-4567
Fax: (908) 756-4483
Email:
General: info@neogenestar.com
Technical support: tech@neogenestar.com
Business Development: bd@neogenestar.com
Place orders: order@neogenestar.com