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 13, 2026, FDA's public records list OraSure Technologies and its 1 subsidiaries with 36 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Jun 10, 2026: Colli-Pee•Dx Urine Collection Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, OraSure Technologies and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 10, 2026 | Colli-Pee•Dx Urine Collection KitK254121 · SIH | 510(k) clearances |
| Oct 27, 2022 | ORAcollect®•DxK212745 · OYJ | 510(k) clearances |
| Feb 18, 2022 | ORAcollect RNA: ORE-100Class II · Evaporation of stabilizing liquid reducing shelf life. | Device recalls |
| Feb 18, 2022 | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.01Class II · Evaporation of stabilizing liquid reducing shelf life. | Device recalls |
| Nov 3, 2021 | OMNIgene GUT DxDEN200040 · QPO | 510(k) clearances |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the remClass III · Reagents were shipped to customers after the Use by data indicated on its labeling. | Device recalls |
| Jan 14, 2020 | Oragene®•DxK192920 · OYJ | 510(k) clearances |
| Oct 10, 2019 | OraQuick Ebola Rapid Antigen TestDEN190025 · QID | 510(k) clearances |
| May 26, 2016 | Oragene DxK152556 · OYJ | 510(k) clearances |
| May 26, 2016 | ORAcollect.DxK152464 · OYJ | 510(k) clearances |
| Feb 19, 2015 | ORAGENE DX OGD-500.001K141410 · OYJ | 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
