Organization name

OraSure Technologies, Inc.

SRN

US-MF-000009941

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 18 countries total.

Trade name

OraQuick® HCV Rapid Antibody Test Kit Controls

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00608337000528

Basic UDI-DI

Basic 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-00608337000528

Reference / catalog number

1001-0278

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

IVDD — Annex II List A

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The OraQuick® HCV Rapid Antibody Test Kit Controls are human plasma-based reagents. The Kit Controls are specifically formulated and manufactured to ensure proper performance of the test. The HCV Positive Control will produce a Reactive test result and has been manufactured to produce a very faint reddish-purple line at the Test (“T”) area. The HCV Negative Control will generate a non-reactive test result (no reddish-purple line at the Test (“T”) area). Refer to Test Result and Interpretation of Test Result section of the OraQuick® HCV Rapid Antibody Test package insert. Use of kit control reagents manufactured by any other source will not meet the requirements for an adequate quality assurance program for the OraQuick® HCV Rapid Antibody Test.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105090202HCV ANTIBODY -RT & POC

• IVDD — Annex II List A medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.