A005

Trade name

not provided

UDI-DI code

06975838803403

Basic UDI-DI

B-06975838803403

Reference / catalog number

A005

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

"This reagent is used for the quantitative determination of total protein content in human serum in vitro. Background of clinical indications: Total serum protein is the most abundant substance in the solid components of serum, and its level mainly reflects the synthetic function of the liver and the loss of protein caused by kidney lesions. A decrease in total protein is usually due to a decrease in albumin. An isolated increase in albumin rarely occurs, except in cases of severe dehydration. A high concentration of total protein is often caused by an increase in one or more types of immunoglobulins, and its elevated concentration can be attributed to dehydration and chronic diseases such as cirrhosis and systemic lupus erythematosus. Conversely, a decrease in total protein can be caused by water intoxication, excessive protein loss, such as burns, nephrotic syndrome, malabsorption, intestinal diseases, or liver diseases."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01010230TOTAL PROTEIN

No certificate specifically references this device's Basic UDI-DI.