Uric Acid (AOX)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Uric Acid (AOX)

UDI-DI code

16438153817885

Basic UDI-DI

6438153BU00186CA

Reference / catalog number

981788

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 uric acid concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Uric Acid (AOX) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of gout diseases, due to hyperuricemia, in patients. Hyperuricemia may be caused for example by acute or chronic kidney disease or increased nucleic acid turnover because of e.g. malignant diseases (leukemia, myeloma), in patients. Furthermore, the urine Uric Acid (AOX) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of the cause of hyperuricemia and for assessing the risk of renal stone formation, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010232URIC ACID

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