Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• CW159

  EUDAMED did not publish a description for this code.
• CW165

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW306

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.
• CW043

  EUDAMED did not publish a description for this code.
• CW999

  P362 + P364: Take off contaminated clothing and wash it before reuse. P501: Dispose of contents/container to an approved waste disposal plant[

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ i TSH

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.

08800111722059

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.

88001117IPBA01IA12VW

Reference / catalog number

16TSH10Q

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

400

Additional product description

STANDARD™ i TSH is an in vitro diagnostic reagent for the quantitative measurement of thyroid stimulating hormone (TSH) 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 thyroid dysfunction, including conditions such as hypothyroidism and hyperthyroidism. 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.

• W01020410THYROID STIMULATING HORMONE

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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