Organization name

İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.

SRN

TR-MF-000047330

Manufacturer status

Active

Primary placement in Türkiye; available across 32 countries total.

Trade name

RevoDx Candidiasis Pathogen Detection Kit

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.

08683079717622

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-08683079717622

Reference / catalog number

IP202301-24

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

RevoDx Candidiasis Pathogen Detection Kit is a real-time PCR test intended for the qualitative detection and identification of nucleic acids of the Candida species in whole blood samples or blood culture samples detected as positive or urine samples or urogenital swabs or cervical swabs. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. Negative results do not preclude the infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

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.

• W0105070599MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER

• IVDD — General medical devices in EUDAMED

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