HbA1c Calibrator

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

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Primary placement in Finland; available across 28 countries total.

Trade name

HbA1c Calibrator

UDI-DI code

16438153002410

Basic UDI-DI

6438153BU00025BH

Reference / catalog number

981863

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

HbA1c Calibrator is used as a stock calibrator of in vitro diagnostic tests for the determination of hemoglobin A1c (HbA1c) and hemoglobin (Hb) in human samples with the automated HbA1c procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.