Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

9 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.
• H261 – In contact with water releases flammable gases.
• 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

Primary placement in Italy; available across 28 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.

08800111724053

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.

88001117IPBA01IA38WG

Reference / catalog number

16INS10F

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

200

Additional product description

STANDARD™ i INS is an in vitro diagnostic reagent for the quantitative measurement of insulin in human serum and EDTA, or Heparin plasma. This fully automated chemiluminescence immunoassay is designed for use on STANDARD™ i Analyzers. The test results are intended to aid in the clinical interpretation of disorders of carbohydrate metabolism, including conditions such as diabetes mellitus and hypoglycemia. 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.

• W0102060103INSULIN

• IVDR Class B medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.