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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

RealAccurate® Quadruplex Color… — IVDR Class A IVDR

MD Atlas
PathoFinder B.V.

EUDAMED last updated this device on Jun 15, 2023

RealAccurate® Quadruplex Color Compensation v5

87193274979PFCC-Rv5QR

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PathoFinder B.V.
UDI-DI code: 08719327497975
Reference / catalog number: PFCC-Rv5

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Manufacturer information

Organization name: PathoFinder B.V.
SRN: NL-MF-000002704
Manufacturer status: Active

Critical warnings

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

CW010
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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Apr 20, 2023	Still on market

Device identification

Trade name: RealAccurate® Quadruplex Color Compensation v5
UDI-DI code: 08719327497975
Basic UDI-DI: 87193274979PFCC-Rv5QR
Reference / catalog number: PFCC-Rv5
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Intended purpose: The RealAccurate Quadruplex Color Compensation kit is an accessory product for the IVDs in the RealAccurate Quadruplex product line. It contains reagents to generate a Color Compensation file to enable use of these IVDs on a LightCycler® 480 / cobas® z480 instrument (Roche), and a reagent to create a custom dye file to enable use of said IVDs on a QuantStudio™ instrument.
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
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Software identification

EMDN nomenclature code(s)

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

W0101050199MULTICOMPONENT CONTROLS (CC) - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.