Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

14 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+P330+P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

  OTHER

• P303+P361+P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse s kin with water/shower.

  OTHER

• P304+P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for brea thing.

  OTHER

• P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

  OTHER

• P310 Immediately call a POISON CENTER or doctor/physician.

  OTHER

• P321 Specific treatment (if in eyes, wash with plenty of running water; if in contact with skin, wash with plenty of running water; if inhaled, move to fresh air; if ingested, seek medical advice on whether to induce vomiting

  OTHER

• P363 Wash contaminated clothing before reuse.

  OTHER

• P405 Store locked up.

  OTHER

• P501 Dispose of contents/container in accordance with local/regional/national/international regulation.

  OTHER

Primary placement in Italy; available across 22 countries total.

Trade name

STANDARD™ M10 MRSA/SA

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.

08800111722219

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.

88001117IPCA01MA22XG

Reference / catalog number

11MSS10A

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 MRSA/SA is a multiplex real-time PCR test designed for use with STANDARD M10 system for the qualitative detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) genes. STANDARD M10 MRSA/SA is intended for use with human nasal swab specimens collected from individuals at risk of nasal colonization or infection with SA, including MRSA. This test is intended to aid in the diagnosis of colonization or infection with MRSA or SA in individuals in healthcare settings. Positive results are the indicative of the presence of spa gene of Staphylococcus aureus, right extremity junction of staphylococcal cassette chromosome mec (SCCmec), and mec gene (mecA or mecC); 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. Negative results do not preclude MRSA or SA 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. It is not intended to guide or monitor treatment. The STANDARD M10 MRSA/SA 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.

• W0105011203SAPHYLOCOCCAL DETECTION BY 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.