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Organization name
UDI-DI code
Reference / catalog number

PlentiPlex™ KIT Mastocytosis qPCR… — IVDR Class C IVDR

MD Atlas
PentaBase A/S

EUDAMED last updated this device on Feb 15, 2026

PlentiPlex™ KIT Mastocytosis qPCR Assay

5713915PP001TD

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PentaBase A/S
UDI-DI code: 05713915000380
Reference / catalog number: 7030

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Manufacturer information

Organization name: PentaBase A/S
SRN: DK-MF-000023157
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
The buffers, primer/probe, and tubes are not to be reused.
CW266
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Apr 7, 2022	Still on market

Device identification

Trade name: PlentiPlex™ KIT Mastocytosis qPCR Assay
UDI-DI code: 05713915000380
Basic UDI-DI: 5713915PP001TD
Reference / catalog number: 7030
Issuing entity: GS1

Classification

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

Device details

Quantity: 12
Additional product description: PlentiPlex™ KIT Mastocytosis qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for in vitro diagnosis of the genomic change giving rise to the aspartic acid to valine mutation in codon 816 of the human KIT proto-oncogene receptor tyrosine kinase (KIT D816V). Samples are genomic DNA (gDNA) purified from blood samples. The assay is used with semi-automated real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The obtained results of PlentiPlex™ KIT Mastocytosis qPCR Assay are intended for the identification of the presence and/or quantity of the KIT D816V mutation as part of the World Health Organization (WHO) diagnostic criteria to assist the diagnosis of Mastocytosis. It is not intended as a companion diagnostic device. PlentiPlex™ KIT Mastocytosis qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples.
Additional information URL: https://5ba.se/pp001
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

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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.