Organization name

Dezhou Guoke Medical Technology Co., Ltd.

SRN

CN-MF-000044128

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  1.This kit is only for in vitro diagnosis, one-time use, please do not re-use. 2.The test kit should be treated as contain infectious material. 3.Please check the integrity and expiration date of the kit packaging before use. 4.Please read the instructions for use of this reagent and instrument carefully before any operation. 5.Please strictly follow the instructions. After the test starts, it cannot be stopped in halfway. If it is stopped halfway, the test cannot be resumed. If a retest is needed, use new reagents and retested. 6.Each batch of reagents has corresponding parameters in the supporting analyzer, and the manufacturer regularly updates the parameters in the analyzer. If the new batch of product reagents is not recognized by the analyzer, please contact the manufacturer in time to update the parameters. 7.The test cassette shall not be used after more than 1 hour after opening. 8.Reagents with different batch numbers cannot be mixed, and ID cards and test cassettes must not be used with mixed batch numbers. 9.The experimental environment should be avoided from being too high. Test cassettes stored at low temperature need to be returned to room temperature before opening to avoid moisture absorption.

Primary placement in Spain; available across 1 country total.

Trade name

Serum Amyloid Protein A (SAA) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)

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.

06977698403168

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-06977698403168

Reference / catalog number

GKPD061

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 in vitro quantitative detection of serum amyloid protein A (SAA) concentration in human whole blood, serum and plasma. Clinically it is mainly used for the identification of viral infections and can be used as a sensitive indicator for diagnosing viral and bacterial infections. As a new generation of inflammatory infection indicators, SAA, combined with CRP and blood routine diagnosis, is the preferred serological indicator to judge viral infection, monitor the course of the disease and the efficacy of medication.

Additional information URL

http://www.guoke-medical.com/static/upload/file/20260402/1775115650395737.pdf

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.

• W01021199RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

• IVDD — General medical devices in EUDAMED

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