981696

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW081

  EUDAMED did not publish a description for this code.
• CW129

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW444

  EUDAMED did not publish a description for this code.
• CW430

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW299

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 25 countries total.

Trade name

not provided

UDI-DI code

16438153816963

Basic UDI-DI

B-16438153816963

Reference / catalog number

981696

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

For in vitro diagnostic use only. HbA1c Control Abnormal is intended for use on Konelab™ and Indiko™ Clinical Chemistry Analyzers as a precision control sample for the HbA1c test.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103010199REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER

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

Certificate health across this manufacturer's portfolio.