Thera-Test Laboratories, Inc.
Thera-Test Laboratories, Inc. holds FDA 510(k) medical device clearance, cleared in 2009, with 2 FDA device recalls on record.
Top product codes for Thera-Test Laboratories, Inc.
FDA recalls by Thera-Test Laboratories, Inc.
- Z-2382-2021 — EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Z-2381-2021 — EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
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 Thera-Test Laboratories, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.