HbA1c Control Abnormal

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW083

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• CW084

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• CW159

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• CW166

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• CW416

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• CW397

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• CW306

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• CW226

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Primary placement in Finland; available across 28 countries total.

Trade name

HbA1c Control Abnormal

UDI-DI code

16438153816963

Basic UDI-DI

6438153BU00026BK

Reference / catalog number

981696

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 Control Abnormal is used as a precision control of in vitrodiagnostic 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.