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US-MF-000009941DGM-585DGM-691OraQuick HCV Rapid Antibody Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by OraSure Technologies, Inc.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 14, 2026
B-10608337000563Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)10608337000563
3 warnings recorded — scroll inside the panel to see all entries.
CW009CW032CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Austria; available across 24 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Sep 26, 2018 | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
10608337000563Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-106083370005631001-0274UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090202HCV ANTIBODY -RT & POCNo certificate specifically references this device's Basic UDI-DI.
B-10608337001515On the marketOraQuickB-10608337001270On the marketOraQuick HCV Rapid Antibody TestB-00608337000566On the marketOraQuick HCV Rapid Antibody TestB-20608337000560On the marketOraQuick HIV Self-TestB-10608337001522On the marketOraQuick HIV Self-TestB-10608337001683On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.