COMPANY

Access Bio

HQ: Monroe Township, NJ source · accessbio.net ↗ · Mid-Atlantic

Also known as ACCESS BIO, INC. · 2 sources

In vitro diagnostics company that has commercialized products to battle malaria and other serious diseases; a partner to international public health agencies and organizations. Source

Keywords: in vitro diagnostics malaria public health diagnostics infectious disease

Location: Monroe Township, NJ · source · Oct 15, 2026

Profile checked Oct 10, 2026

2FDA records (2 yrs)

Timeline

Aug 22, 2025 FDA FDA 510(k) clearance: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test — K251604, Aug 22, 2025. Applicant at approval: Access Bio, Inc. source ↗
Jan 29, 2025 FDA FDA 510(k) clearance: CareSuperb COVID-19 Antigen Home Test — K241915, Jan 29, 2025. Applicant at approval: Access Bio, Inc. source ↗

FDA records (last 2 years)

Aug 22, 2025 FDA 510(k) clearance: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test — K251604, Aug 22, 2025. Applicant at approval: Access Bio, Inc. source ↗
Jan 29, 2025 FDA 510(k) clearance: CareSuperb COVID-19 Antigen Home Test — K241915, Jan 29, 2025. Applicant at approval: Access Bio, Inc. source ↗