INDIKO ISE Calibrator 1

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW129

  Contains Isothiazolinone compounds

Primary placement in Finland; available across 28 countries total.

Trade name

INDIKO ISE Calibrator 1

UDI-DI code

16438153004070

Basic UDI-DI

6438153BU00135BR

Reference / catalog number

984032

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 The ISE Calibrators are used for calibration of ion selective electrodes of in vitro diagnostic tests for the determination of potassium (K+), sodium (Na+), chloride (Cl-), lithium (Li+) and ionized calcium (Ca2+, including pH measurement) concentrations in human samples with the automated 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.

• W0101050301CALIBRATORS MULTICOMPONENT (CC)

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

Certificate health across this manufacturer's portfolio.