BaseTyper

Organization name

PentaBase A/S

SRN

DK-MF-000023157

Manufacturer status

Active

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

• CW258

  Indicates potential hot instrument surfaces, reminding the operating personnel to take care
• CW008

  Indicates an area that might may be contaminated with biological contaminants

Primary placement in Denmark; available across 1 country total.

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

Trade name

BaseTyper

UDI-DI code

05713915000144

Basic UDI-DI

5713915BT002PH

Reference / catalog number

712

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The BaseTyper™ 16.2 Portable Real-Time PCR System is intended for performing silent, rapid, and accurate Polymerase Chain Reactions (PCR), Reverse Transcriptase PCR (RT-PCR), quantitative PCR (qPCR), and fluorescence-based melt analyses. The BaseTyper™ 16.2 Portable Real-Time PCR System obtains real-time measurements of signals from up to 16 samples in each run. Sample material is normally genetic material like RNA and DNA. The BaseTyper™ 16.2 Portable Real-Time PCR System can easily be moved close to the sample of interest and be used in as well as outside laboratories. can be used for downstream applications, to aid in the screening, monitoring and/or diagnosis of diseases. Each well can be analysed using fluorescence in up to four different fluorescent channels. The fluorescent signals can for example originate from DNA-binding fluorescent dyes or labelled probes. Signals can be converted to qualitative, semi-quantitative or quantitative readouts. The fluorescent signals can for example originate from DNA-binding fluorescent dyes or labeled probes. Signals can be converted to presence, comparative quantities, and/or physical-chemical property readouts. The instrument is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of PCR.

Additional information URL

https://www.5ba.se/BT002

Clinical sizes

No clinical sizes registered for this device.

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

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

• W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS