OraQuick Ebola Rapid Antigen Test
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- OraQuick EUDAMED
- Device Name
- OraQuick HIV Self-Test, CE, UK, 25 Count Kit EUDAMED
- Model / Reference
- 1001-0600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10608337001270 EUDAMED
- Basic UDI-DI
- B-10608337001270 EUDAMED
- 510(k) Number
- DEN190025 FDA 510(k)
- FDA Product Code
- QID FDA 510(k)
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.4002 FDA 510(k)
- Regulation Number
- 866.4002 FDA 510(k)
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
No
Self Testing
Yes
Near-Patient Testing
Yes
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
The OraQuick Ebola Rapid Antigen Test is a device classified as a Device to Detect Antigens of Biothreat Microbial Agents in Human Clinical Specimens, designed for the rapid identification of Ebola virus antigens in patient samples. It operates as a point-of-care diagnostic tool, providing results within a short timeframe to support clinical decision-making in microbiology settings.
This test is supplied as a single-use, in vitro diagnostic device intended for use in regulated clinical environments, including laboratories and emergency response settings. It is authorized under FDA 510(k) clearance and meets the requirements of the In Vitro Diagnostic Device Directive (IVDD). The device is packaged for individual use and must be stored according to manufacturer instructions to maintain its performance and sterility.
Frequently asked questions
What clinical setting is the OraQuick Ebola Rapid Antigen Test intended for use in, and how quickly does it provide results?
The OraQuick Ebola Rapid Antigen Test is designed for point-of-care use in regulated clinical environments like microbiology laboratories and emergency response settings. It is specifically intended for rapid identification of Ebola virus antigens in human clinical specimens. Results are provided within a short timeframe, enabling quick clinical decision-making.
Is the OraQuick Ebola Rapid Antigen Test reusable, and how is it packaged for use?
No, the OraQuick Ebola Rapid Antigen Test is a single-use device. It is supplied individually packaged for each test, ensuring sterility and preventing cross-contamination between uses.
What regulatory pathways has the OraQuick Ebola Rapid Antigen Test followed, and what does this mean for its use?
The OraQuick Ebola Rapid Antigen Test has been authorized under both FDA 510(k) clearance and the In Vitro Diagnostic Device Directive (IVDD). This means it has undergone regulatory review to ensure its safety, performance, and compliance with standards for detecting Ebola virus antigens in human clinical specimens, making it suitable for use in clinical and emergency settings.
How should the OraQuick Ebola Rapid Antigen Test be stored to maintain its performance?
The device must be stored according to the manufacturer’s instructions to preserve its performance and sterility. While the exact storage conditions are not detailed here, typical rapid antigen tests require protection from extreme temperatures, moisture, and light. Always refer to the included instructions for precise storage guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN190025 | Class II | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (2)
- FDA 510(k) DEN190025 24 fields · synced Sep 18, 2026
- EUDAMED bbe69c73-0a37-4326-8211-54251341e2fc 61 fields · synced Jul 11, 2026