Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• H317 – May cause an allergic skin reaction.
• H412 – Harmful to aquatic life with long lasting effects.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• 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

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

  OTHER

Primary placement in Italy; available across 27 countries total.

Trade name

STANDARD™ i β-hCG

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.

08800111724169

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.

88001117IPBA01IA15W4

Reference / catalog number

16BHC10D

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

100

Additional product description

STANDARD™ i β-hCG is an in vitro diagnostic reagent for the quantitative measurement of human chorionic gonadotropin (hCG) in human serum. This fully automated chemiluminescence immunoassay is designed for use on STANDARD™ i Analyzers. The test results are intended to aid in the early detection of pregnancy. The device is intended for use by trained laboratory professionals in a clinical laboratory environment and is not intended for near-patient, point-of-care, or lay use.

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.

• W0102050206B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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