Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay)

Organization name

Beijing Kinghawk Pharmaceutical CO., Ltd

SRN

CN-MF-000052726

Manufacturer status

Active

Primary placement in Spain; available across 1 country total.

Trade name

Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay)

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.

06971140521127

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-06971140521127

Reference / catalog number

0201002843

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

This kit is intended for the in vitro qualitative detection of Leptospira IgG/IgM in human whole blood serum or plasma samples. The test results are for preliminary assessment only and are not intended to be used as the sole basis for clinical diagnosis. Reactive results should be further evaluated in conjunction with other laboratory methods and clinical findings. This product is intended for the rapid auxiliary detection and epidemiological surveillance of Leptospira infection and is for professional use only. Leptospira are spiral-shaped bacteria that include both pathogenic and non-pathogenic species. Pathogenic Leptospira can cause leptospirosis in humans and animals, which is a globally distributed zoonotic disease. Leptospira enter the human body through damaged skin or mucous membranes. Following an incubation period of approximately 7–10 days, the organisms disseminate into the bloodstream and multiply, resulting in early leptospiremia. Clinical manifestations during this phase may include fever, chills, myalgia, headache, conjunctival suffusion, and calf muscle tenderness.The organisms may persist in the bloodstream for approximately one month and can subsequently invade multiple organs, including the liver, spleen, kidneys, lungs, heart, lymph nodes, and central nervous system, potentially leading to organ dysfunction and corresponding clinical manifestations.

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.

• W01050499VIROLOGY REAGENTS - OTHER

• IVDD — General medical devices in EUDAMED

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