Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• 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.
• 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.
• P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. - P310 Immediately call a POISON CENTER or doctor/physician. - P321 Specific treatment - P363 Wash contaminated clothing before reuse. - P501 Dispose of contents/container in accordance with local/regional/national/international regulation.

  OTHER

• H314 – Causes severe skin burns and eye damage.
• H318 – Causes serious eye damage.
• Do not re-use
• Contains biological material of animal origin
• Do not use if package is damaged

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ M10 STI Panel

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.

08800111719004

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.

88001117IPCA01MA10X9

Reference / catalog number

11STI10A

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

STANDARDM10 STI Panel is a multiplex real-time PCR test intended for use with STANDARD M10 system to qualitatively detection of sexually transmitted infection (STI) pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Human herpes virus 1, Human herpesvirus 2, Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, and Ureaplasma urealyticum in urine specimens collected from asymptomatic and symptomatic individuals suspected of having STI. It is intended as an aid to diagnosis a patient's infection status. Determining a patient's infection status requires clinical correlation with the patient's medical history and other diagnostic information. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude sexually transmitted 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.

• W0105070501STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX 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.