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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 Atypical… — IVDD — General IVDD

MD Atlas
PathoFinder B.V.

EUDAMED last updated this device on Jun 14, 2023

RealAccurate® Quadruplex Atypical Bacteria PCR kit

B-08719327497944

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PathoFinder B.V.
UDI-DI code: 08719327497944
Reference / catalog number: PF0966-R

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Manufacturer information

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

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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.

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	May 17, 2022	Still on market

Device identification

Trade name: RealAccurate® Quadruplex Atypical Bacteria PCR kit
UDI-DI code: 08719327497944
Basic UDI-DI: B-08719327497944
Reference / catalog number: PF0966-R
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: RealAccurate® Quadruplex Atypical Bacteria PCR kit is a CE marked multiplex PCR-based test to detect and differentiate Mycoplasma pneumoniae and Legionella pneumophila.
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

EMDN nomenclature code(s)

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

W0105010503LEGIONELLA DETECTION BY NA REAGENTS
W0105010803MYCOPLASMA DETECTION BY NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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