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.
• P273 – Avoid release to the environment.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P305 – IF IN EYES: P321 – Specific treatment (see on this label).
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.

Primary placement in Austria; available across 27 countries total.

Trade name

STANDARD™ i Cortisol

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.

08800111723506

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.

88001117IPCA01IA36WX

Reference / catalog number

16COR10Q

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

1

Additional product description

STANDARD™ i Cortisol is an in vitro diagnostic reagent for the quantitative measurement of cortisol 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 adrenal gland dysfunction, including conditions such as Addison’s disease and Cushing’s syndrome. 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.

• W0102060203CORTISOL

• IVDR Class B medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.