Phosphorus

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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Primary placement in Finland; available across 28 countries total.

Trade name

Phosphorus

UDI-DI code

16438153818905

Basic UDI-DI

6438153BU00183C4

Reference / catalog number

981890

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 inorganic phosphate concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Phosphorus test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of abnormal inorganic phosphate levels (hypophosphatemia or hyperphosphatemia), which can lead to significant bone disorders, in patients. Reasons of hypo- and hyperphosphatemia can be for example renal tubular defects, renal failure, respiratory alkalosis, parathyroid diseases or oncogenic osteomalacia.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010307PHOSPHATE INORGANIC / PHOSPHORUS

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

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