EUDAMED last updated this device on Jul 7, 2026

PCT/IL-6 Test Kit (FIA)

B-06973841001434

On the marketIVDD — General

Applicable legislation: —
Organization name: Guangdong Wesail Biotech Co., Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06973841001434
Reference / catalog number: BA0400

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

PCT/IL-6 Test Kit (FIA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Guangdong Wesail Biotech Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: PCT/IL-6 Test Kit (FIA)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06973841001434
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. View in glossary →: B-06973841001434
Reference / catalog number: BA0400
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: This kit applies to the quantitative determination of procalcitonin (PCT) and Interleukin-6 (IL-6) in human serum, plasma and whole blood. It is primarily used for auxiliary diagnosis of bacterial infectious diseases and for monitoring the body's immune status, inflammatory response, and related conditions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06973841001434

EMDN nomenclature code(s)

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

W01021199RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

Consult instructions for use
Do not re-use
Do not use if package is damaged
Do not use past indicated date

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	—	Still on market

PCT/IL-6 Test Kit (FIA)

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Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Manufacturer information

Certificates covering this device

Certificates

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