Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• P273 – Avoid release to the environment.
• P391 – Collect spillage.
• Do not use if package is damaged

  STANDARD™ F HbA1c should remain in its original sealed pouch until ready to use. Do not use the test kit if the pouch is damaged or the seal is broken. Before testing, check the latex tablet in the Spoit™ if it is not contaminated or broken.

• Contains hazardous substances

  The extraction buffer contains preservatives, including sodium azide and ProClin 300.

Primary placement in Italy; available across 24 countries total.

Trade name

STANDARD™ F HbA1c

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.

08800111725661

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.

88001117IPCA01FA05VX

Reference / catalog number

10A1C20B

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

20

Additional product description

STANDARD™ F HbA1c is an in vitro diagnostic system for the quantitative measurement of hemoglobin A1c in human capillary or venous whole blood. 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. STANDARD™ F HbA1c is intended as an aid in the diagnosis of diabetes and for monitoring longterm blood glucose control in people with diabetes. Test results from this kit must be analyzed using the STANDARD™ F Analyzer, a suitable semiautomated 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.

• W0102160102GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.