Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• Caution

  If there is evidence of microbial contamination in the reconstituted control, discard the control.

• Clean any spillage by immediately and thoroughly wipe up with a suitable disinfectant such as 1% sodium hypochlorite solution.

  OTHER

• Contains biological material of human origin

  Handle and dispose of all controls and materials used in testing in accordance with standard laboratory practices and local regulations. This control contains human hemoglobin tested negative for HIV, HBV and HCV. Handle as potentially infectious.

Primary placement in Italy; available across 23 countries total.

Trade name

SDB HbA1c Control

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.

08800111725678

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.

88001117IPCA02FA05WA

Reference / catalog number

10A1CC20

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

SDB HbA1c Control is intended for use as a quality control material to monitor the performance of STANDARD™ F HbA1c. This test is for in vitro diagnostic use only and is intended to be used by trained laboratory professionals in a clinical laboratory setting, and by healthcare professionals including nurses, physicians, and healthcare assistants in near-patient testing environments such as outpatient clinics, emergency departments, and primary care facilities. Test results from this kit must be analyzed using the STANDARD™ F Analyzer, a suitable semi-automated analyzer manufactured by SD BIOSENSOR. The test is intended for near-patient testing (NPT) and it is not intended for self-testing by lay users.

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.

• W0102160801CONTROLS IMMUNOCHEM - RT & POC

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.