- Available products are for use in the following manner and intended for professional use (Healthcare Providers) and not for home use.
- These tests has been authorized by FDA under an EUA for emergency use limited by authorized laboratories and Point of Care (POC) settings as indicated. Tests have not been FDA cleared or approved. Antibody tests been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. (ANTIGEN test only- is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.)
- These test are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Positive Antibody results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- COVID-19 Antigen test is a lateral flow immunochromatographic assay, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Please review Instructions for Use.
Contact 866-544-7678 for Questions
CareStart COVID-19 ANTIGEN test by Access Bio, Inc.
Order in Quantities of 20 Minimum order is 100 test kits, 5 boxes ***due to demand, expect 7-14 days for delivery** Call 866-544-7678 if ordering more than 1000
- Lateral Flow assay
- No equipment required
- Rapid results within 10 minutes
- Minimally invasive specimen collection (nasopharyngeal swabs)
- Intended POC setting (i.e., in patient care settings) by medical professionals
20 Kits per box. FDA / EUA Authorized CLIA Waived
Assure COVID-19 IgG/IgM Rapid Test Device
Healgen COVID-19 IgG/IgM Rapid Test Cassette
Single-Use Face Shields
Ready-to-Wear (Part #FBFS)
1000 Qt minimum (5 cases)
- Clear Shield Material: Printed 0.010” PET (0.25mm)
- Clear Shield Dimensions: 12.6” wide x 8.7” high (320 mm x 220 mm)
- Forehead Pad: Open-cell polyurethane foam
- Stretch Headband: 1” wide knitted polyester elastic