Calcium

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Calcium

UDI-DI code

16438153007316

Basic UDI-DI

6438153BU00127BS

Reference / catalog number

981953

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 calcium concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Calcium test for serum and plasma is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of decreased calcium levels (hypocalcemia) and increased calcium levels (hypercalcemia) due to various disorders and diseases of bone and parathyroid gland, gastrointestinal tract or kidney, in patients. Furthermore, the Calcium test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of vitamin D deficiency or resistance, which leads to hypocalcemia, in patients. The Calcium test for urine is indicated to be used in conjunction with clinical evaluation for aid to assess the excretion of calcium from the kidneys and for disease assessment, such as renal stone disease or high-turnover osteoporosis, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010303CALCIUM

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