1398;1402;1400;1831;1836;1841

Organization name

PentaBase A/S

SRN

DK-MF-000023157

Manufacturer status

Active

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

• CW009

  Do not reuse PCR tubes and/or any of the other components within the kit.

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-5713915SS001V3PX

Basic UDI-DI

B-5713915SS001V3PX

Reference / catalog number

1398;1402;1400;1831;1836;1841

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® FFPE BRAF qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic v-Raf murine sarcoma viral oncogene homolog B (BRAF) gene mutations in human DNA purified from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. SensiScreen® FFPE BRAF qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the BRAF somatic mutational status as an aid in selecting the proper treatment of cancer. SensiScreen® FFPE BRAF 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. Medical interventions based on results from this product requires medical authorization.

Additional information URL

https://www.5ba.se/SS001

Clinical sizes

No clinical sizes registered for this device.

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

D-5713915SS001V3PX

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