Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation)

Organization name

Biobase Biodustry(Shandong) Co.,Ltd.

SRN

CN-MF-000025015

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Trade name

Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06971674868835

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-06971674868835

Reference / catalog number

R1:48mL×2 R2:24mL×1（791）

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Used for the quantitative detection of total bilirubin (TBIL) levels in human serum or plasma. This product is not suitable for use in newborn testing.Bilirubin is formed from the degradation of hemoglobin released after the destruction of red blood cells, with 80% of bilirubin originating from the spleen and liver, while the remaining bilirubin comes from the bone marrow. There are three forms of bilirubin: unbound bilirubin, conjugated bilirubin, and δ-bilirubin, collectively referred to as total bilirubin. Among these, conjugated bilirubin and δ-bilirubin can directly react with diazo reagents, known as direct bilirubin. An increase in total bilirubin levels is associated with elevated direct and indirect bilirubin levels, commonly seen in hepatocellular jaundice, such as acute hepatitis, severe hepatitis, chronic active hepatitis, and cirrhosis; an increase in total bilirubin and direct bilirubin levels is observed in obstructive jaundice, such as biliary stones and biliary obstruction; an increase in total bilirubin and indirect bilirubin levels is commonly seen in hemolytic jaundice. This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results.Clinically, the main methods for detecting total bilirubin include vanadate oxidation, diazo method, and oxidase method.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• W01010203BILIRUBIN

• IVDD — General medical devices in EUDAMED

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