Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

11 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.
• 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.

  OTHER

Primary placement in Italy; available across 24 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.

08800111722158

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.

88001117IPBA01MA03WR

Reference / catalog number

11FLU30A

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 B

Applicable legislation

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

Status

On the market

Quantity

10

Additional product description

STANDARD M10 Flu/RSV/SARS-CoV-2 Fast test, performed on the STANDARD M10 system, is an automated multiplexed realtime RT-PCR assay intended for the simultaneous in vitro qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens collected from individuals presenting signs and symptoms of respiratory tract infection. The test is intended to aid in the diagnosis of COVID-19, influenza, and/or RSV infections and it is for professional use only and is intended to be used by clinical laboratory professionals or healthcare professionals who have received general professional training appropriate to their role. The test is designed for use in clinical laboratories or near-patient testing environments, such as healthcare facilities and other adequately equipped healthcare settings. Positive results are indicative of the presence of Influenza A, Influenza B, RSV and/or

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.

• W0105070302OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.