Phosphorus

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW073

  EUDAMED did not publish a description for this code.
• CW149

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

  EUDAMED did not publish a description for this code.
• CW225

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 29 countries total.

Trade name

Phosphorus

UDI-DI code

16438153020032

Basic UDI-DI

6438153BU02002BK

Reference / catalog number

981951

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

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™ 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

Certificate health across this manufacturer's portfolio.