5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601

Organization name

PentaBase A/S

SRN

DK-MF-000023157

Manufacturer status

Active

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

• CW009

  The buffers, primer/probe, and tubes are not to be reused.

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Trade name

not provided

UDI-DI code

D-5713915SS010V4Q3

Basic UDI-DI

B-5713915SS010V4Q3

Reference / catalog number

5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

SensiScreen® Liquid PIK3CA qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic mutations in the human phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) gene in cell-free DNA (cfDNA) purified from liquid biopsies including blood and plasma. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The assay is an in vitro diagnostic medical device intended to aid in the detection, identification, monitoring of disease progression, and re-appearance based on PIK3CA mutation status. The test result correlates with the amount of PIK3CA mutant cfDNA. Result can be used to determine changes in PIK3CA mutation quantity levels in patients over time such as during cancer interventions and as an aid in selecting proper treatment of cancer. SensiScreen® Liquid PIK3CA qPCR Assay is intended to be used 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. Medical interventions based on results from this product requires medical authorization.

Additional information URL

https://www.5ba.se/SS010

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-5713915SS010V4Q3

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER