Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list InBios International, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Oct 12, 2025: COVID-19 Detect Rapid Self -Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 12, 2025 | COVID-19 Detect Rapid Self -TestK251595 · QYT | 510(k) clearances |
| Aug 23, 2024 | SCoV-2 Ag Detect Rapid TestK233358 · QVF | 510(k) clearances |
| Feb 3, 2023 | Active Anthrax DetectTM Plus Rapid TestDEN220044 · QUU | 510(k) clearances |
| May 23, 2019 | ZIKV Detect 2.0 IgM Capture ELISADEN180069 · QFO | 510(k) clearances |
| Aug 27, 2018 | DENV Detect NS1 ELISAK181473 · QCU | 510(k) clearances |
| Dec 16, 2016 | Chagas Detect Plus Rapid TestK161947 · MIU | 510(k) clearances |
| Nov 14, 2014 | CL DETECT RAPID TESTK141341 · PIT | 510(k) clearances |
| Apr 8, 2011 | DENV DETECT IGM CAPTURE ELISADEN100020 · OSU | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
