Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• H314 – Causes severe skin burns and eye damage.
• H318 – Causes serious eye damage.
• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.
• P264 – Wash thoroughly after handling.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P301 – IF SWALLOWED: P330 – Rinse mouth.
• P301 – IF SWALLOWED: P331 – Do NOT induce vomiting.
• P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.
• P303 – IF ON SKIN (or hair): P353 – Rinse skin with water/shower.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• - P310 Immediately call a POISON CENTER or doctor/physician. - P321 Specific treatment. - P363 Wash contaminated clothing before reuse. - P405 Store locked up. - P501 Dispose of contents/container in accordance with local/regional/national/international regulation.

  OTHER

Primary placement in Italy; available across 28 countries total.

Trade name

STANDARD™ M10 vanA/vanB

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.

08800111723100

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.

88001117IPCA01MA20XC

Reference / catalog number

11VAN10A

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

STANDARD M10 vanA/vanB is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of vanA and/or vanB genes in rectal swab specimens in patients at risk of intestinal colonization with vancomycin-resistant Enterococci (VRE). This test is designed to aid in the diagnosis of colonization or infection with VRE in patients in healthcare settings. Results are for the identification of vanA/vanB DNA. Positive results are indicative of the presence of vanA and/or vanB DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out virus infection or co-infection with other bacteria. The agent detected may not be the definite cause of disease. Negative results do not preclude VRE infection 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 trained users in a laboratory setting and is not intended for use in near-patient testing environments.

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.

• W0105011699BACTERIOLOGY - NA REAGENTS - OTHER

• IVDR Class C medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.