Sd Biosensor, Inc.
Sd Biosensor, Inc. holds FDA 510(k) medical device clearances, cleared in 2015, with 2 FDA device recalls on record.
Top product codes for Sd Biosensor, Inc.
FDA recalls by Sd Biosensor, Inc.
- Z-1594-2023 — Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
- Z-0719-2022 — STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sd Biosensor, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.