Retinol-binding Protein (RBP) Test Kit (Immunoturbidimetric)

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

Retinol-binding Protein (RBP) Test Kit (Immunoturbidimetric)

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.

06936895313335

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-06936895313335

Reference / catalog number

R1:60ml×5 R2:20ml×5（795）

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 retinol-binding protein (RBP) content in human serum in vitro. RBP is a specific binding protein for vitamin A in the blood, playing an important role in the metabolism of vitamin A, synthesized by the liver, and widely distributed in blood, cerebrospinal fluid, urine, and other body fluids. Determining RBP can help in the early detection of tubular dysfunction in the kidneys, and it can sensitively reflect the degree of damage to the proximal renal tubules. It can also serve as an indicator of early liver function damage and monitoring treatment. Decreased serum RBP concentration is commonly observed in vitamin A deficiency, liver, and biliary diseases. Additionally, in conditions like malabsorption syndromes, obstructive jaundice, cirrhosis, severe infections, and hyperthyroidism, serum RBP concentration may be reduced. Increased serum RBP concentration is commonly found in kidney diseases that lead to reduced glomerular filtration rate, while diseases causing elevated serum RBP concentration are less common.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. In clinical practice, the main method for detecting retinol-binding protein is the immunoturbidimetric 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.

• W0102010306RETINOL BINDING PROTEIN

• IVDD — General medical devices in EUDAMED

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