Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW007

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ M10 Hr-HPV

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.

08800111721991

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.

88001117IPCA01MA18XR

Reference / catalog number

11HPV20A

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.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

10

Additional product description

The STANDARD M10 Hr-HPV test is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of Human papillomavirus (HPV) DNA in cervical specimens collected by healthcare providers. The STANDARD M10 Hr-HPV is used for the detection of a highrisk HPV infection, which is associated with increased risk of cervical precancerous lesions and cervical cancer. The STANDARD M10 Hr-HPV separately detects genotypes 16, 18 and reports 12 high-risk HPV types (i.e., 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) in a pooled result. The STANDARD M10 Hr-HPV is indicated for use as a cervical cancer screening test to assess the presence or absence of high risk HPV genotypes. Results are for the identification of 14 high-risk HPV DNA genotypes. Positive results are indicative of the presence of HPV DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude HPV infection(or cervical cancer) and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. This test is intended to be performed by health-care professionals in a laboratory setting or health-care institution.

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.

• W0105041002SCREENING HIGH-RISK HPV - NA REAGENTS

• IVDR Class C medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.