Aspartate Aminotransferase (AST) Test Kit (Aspartate)

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

Aspartate Aminotransferase (AST) Test Kit (Aspartate)

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.

06971674861928

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-06971674861928

Reference / catalog number

R1:20mL×4 R2:5mL×4(707)

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

For the in vitro quantitative determination of the activity of aspartate aminotransferase (AST) in human serum or plasma. Clinically, AST is mainly used for the auxiliary diagnosis of myocardial infarction, toxic hepatitis, skeletal muscle diseases, and other conditions. AST is abundant in myocardial cells; when myocardial infarction occurs, the activity of AST in serum increases. AST can be elevated in various liver diseases: in the early stage of liver disease and chronic liver disease, the AST/ALT ratio is less than 1; in severe liver disease and the advanced stage of liver disease, the AST/ALT ratio is greater than 1. In other conditions such as myocarditis, nephritis, and pneumonia, AST can also increase slightly. Therefore, the determination of AST holds important significance for the detection of heart and liver diseases. 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.The main methods used for aspartate aminotransferase detection in clinical practice include the rate method, continuous monitoring method, and ultraviolet continuous monitoring 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.

• W01010110ASPARTATE AMINO-TRANSFERASE

• IVDD — General medical devices in EUDAMED

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