Organization name

Self-screen B.V.

SRN

NL-MF-000040204

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

not provided

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.

04053228029083

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-04053228029083

Reference / catalog number

616014

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 — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The QIAsure Methylation Test (cat. no. 616014) is a multiplex real-time methylation-specific PCR assay for the detection of promoter hypermethylation of the genes FAM19A4 and hsamir124- 2. Samples that may be tested with QIAsure Methylation Test include bisulfite-converted DNA isolated from specimens collected in the following ways:  Cervical specimens collected with the digene® HC2 DNA Collection Device (physician collected)  Cervical specimens collected using a brush/broom-type collection device and placed in PreservCyt® Solution or in SurePathTM Solution (physician collected)  Vaginal specimens collected using a brush/broom device (self-collected) Indications for use: 1. As a follow-up test for women with a positive human papillomavirus (HPV) test, to determine the need for referral to colposcopy or other follow-up procedures. 2. As a follow-up test for women with Pap test results with atypical squamous cells of undetermined significance (ASC-US), to determine the need for referral to colposcopy or other follow-up procedures. This product is intended to be used by professional users, such as technicians and laboratorians who are trained in in vitro diagnostics procedures, molecular biological techniques, and the Rotor-Gene Q MDx 5plex HRM system.

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.

• W010699GENETIC TESTS - OTHER

• IVDD — General medical devices in EUDAMED

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