Data / Medical devices / United States / Orasure Technologies, Inc.
Orasure Technologies, Inc.: FDA-registered device maker in Bethlehem, PA, United States, 6 510(k) clearances and 1 PMA approval
Orasure Technologies, Inc. is registered with the FDA (registration 3022474803) in Bethlehem, PA, United States. It lists 11 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated November 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022474803
- Address
- 2685 Opus Way --, Bethlehem, PA, United States, 18020
- Owner or operator
- ORASURE TECHNOLOGIES, INC. (9000083)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 19, 2007
- Registered through
- 2026
- Brand names listed
- InteliSwab COVID-19 Rapid Test, InteliSwab COVID-19 Rapid Test Pro, InteliSwab COVID-19 Rapid Test Rx, OMNIgene GUT (ME-200), OMNIgene GUT (OMR-200), OMNIgene ORAL (OM-501, OMR-110, OMR-120), OMNIgene ORAL (OM-505, OME-505), OMNIgene SKIN (OMR-140) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2021 | DEN200040 | OMNIgene GUT Dx | QPO | Unknown | DNA Genotek, Inc. | accessdata.fda.gov |
| January 14, 2020 | K192920 | Oragene®Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| October 10, 2019 | DEN190025 | OraQuick Ebola Rapid Antigen Test | QID | Unknown | OraSure Technologies, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152556 | Oragene Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152464 | ORAcollect.Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| December 2, 2011 | K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 25, 2010 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 35 | April 20, 2021 | accessdata.fda.gov |
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Updated November 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.