OraQuick HCV Rapid Antibody Test
FDA PMAEUDAMEDClass II (US FDA PMA)
Identity
- Trade Name
- ORAQUICK HCV RAPID ANTIBODY TEST EUDAMEDFDA PMA
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus FDA PMA
- Device Name
- OraQuick HCV Rapid Antibody Test, Pouched Device EUDAMEDOraQuick HCV Rapid Antibody Test, 25 Count EUDAMEDOraQuick HCV Rapid Antibody Test, 100 Count EUDAMED
- Model / Reference
- 3001-2141 EUDAMED1001-0270 EUDAMED1001-0274 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00608337000566 EUDAMED20608337000560 EUDAMED10608337000563 EUDAMED
- Basic UDI-DI
- B-00608337000566 EUDAMEDB-20608337000560 EUDAMEDB-10608337000563 EUDAMED
- PMA Number
- P080027 FDA PMA
- FDA Product Code
- MZO FDA PMA
- EMDN Code
- W0105090202 HCV ANTIBODY -RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMEDClass II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3169 FDA PMA
- Regulation Number
- 866.3169 FDA PMA
- Market of Registration
- Austria EUDAMEDBulgaria EUDAMED
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
The OraQuick HCV Rapid Antibody Test is an in vitro diagnostic device indicated for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. It is intended to provide presumptive evidence of HCV infection when used with other laboratory results and clinical information in persons with signs or symptoms of hepatitis or at risk for HCV infection.
The test is supplied as a kit for use in clinical or point-of-care settings. It is a single-use device and is not sterile. Storage conditions and handling procedures should follow the manufacturer’s labeling. The device has received FDA PMA approval (P080027) and is classified as a Class II device under regulation 866.3169.
Frequently asked questions
What specimen types are acceptable for use with the OraQuick HCV Rapid Antibody Test?
The test is indicated for use with venipuncture whole blood specimens collected in EDTA, sodium heparin, lithium heparin, or sodium citrate anticoagulants. These are the only specimen types specified in the device’s authorization for qualitative detection of anti-HCV.
Is the OraQuick HCV Rapid Antibody Test a sterile device?
The device data does not state that the OraQuick HCV Rapid Antibody Test is sterile. It is described as a single-use test, but no sterility claim is included in the specifications or authorization details provided.
What is the regulatory classification and authorization number for the OraQuick HCV Rapid Antibody Test?
The device is classified as a Class II medical device under FDA regulation 866.3169 and has received FDA Premarket Approval (PMA) under number P080027, as stated in the AUTHORIZATIONS and openfda fields.
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_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA PMA | United States | FDA_PMA | P080027 | Class II | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (4)
- FDA PMA P080027 24 fields · synced Sep 18, 2026
- EUDAMED 86eb86c3-6a41-4a2d-8334-41c59cf8936c 61 fields · synced Jul 16, 2026
- EUDAMED e91b003a-6211-44cc-ab27-92218fc58aba 61 fields · synced Jul 16, 2026
- EUDAMED a661d372-a14d-4119-8f5b-64242de37921 61 fields · synced Jul 28, 2026