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

Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex 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.

06971674868187

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-06971674868187

Reference / catalog number

Calibrator：1mL×2(91064)

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 in vitro quantitative determination of anti-cyclic citrullinated peptide antibody levels in human serum. Anti-cyclic citrullinated peptide antibodies (CCP) have good sensitivity and specificity for rheumatoid arthritis (RA), making them one of the important indicators for the early diagnosis of RA, and they assist in the early auxiliary diagnosis of rheumatoid arthritis.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 detection of anti-cyclic citrullinated peptide antibodies mainly employs the latex immunoturbidimetry method, as well as enzyme-linked immunosorbent assay (ELISA) and colloidal gold methods.

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.

• W01021112ANTI-CYCLIC CITRULLINATED PEPTIDE

• IVDD — General medical devices in EUDAMED

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