Iron

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

9 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

Iron

UDI-DI code

16438153812361

Basic UDI-DI

6438153BU00134BP

Reference / catalog number

981236

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of iron concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Iron test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of excessive iron intake (intoxication) and iron overload diseases for example due to hemochromatosis, in patients. The Iron test is furthermore indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of iron deficiency and anemia, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010216IRON (CC)

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

Certificate health across this manufacturer's portfolio.