HbA1c

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW011

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

  Contains 2-methyl-2H-isothiazole-3-one
• CW159

  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.
• CW999

  P362+P364: Take off contaminated clothing and wash before reuse

Primary placement in Finland; available across 28 countries total.

Trade name

HbA1c

UDI-DI code

16438153002403

Basic UDI-DI

6438153BU00022BB

Reference / catalog number

981948

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

For in vitro diagnostic use in the quantitative determination of relative hemoglobin A1c (HbA1c) concentration in hemolyzed human blood with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The HbA1c test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of diabetes mellitus and long-term monitoring of glycemia, in patients. Furthermore, the HbA1c test is indicated to be used in conjunction with clinical evaluation for assessing response to diabetes treatment and for predicting the development of microvascular complications, in patients.

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.