Organization name

Bee Robotics

SRN

GB-MF-000023998

Manufacturer status

Active

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

• For warning and precautions refer to the IFU

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

SelectNA Plus

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05060969430077

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

506096943R12XHBR01YQ

Reference / catalog number

R12-XH-MM-01

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 Select NA Plus is a semi-automated standalone Class A in vitro diagnostic instrument used for pathogen enrichment and DNA extraction of up to 12 samples. The Select NA Plus uses XYZ mechanism for the liquid handling and a column assembly for processing the columns to draw reagents through the filter using dedicated vacuum pumps. The extracted DNA is automatically transferred into a PCR tube for analysis by a PCR instrument. The Select NA Plus allows for automation and quantitative determination of PCR based assays using a variety of specimens which include (but not limited to): - EDTA Blood - Bronchoalveolar lavage - Ascites fluid - Joint aspirates - CSF - Swabs - Sonicate fluids - Various tissue biopsies The assays include (but not limited to) testing for: - Septicaemia - Joint, Bone and wound infections - Periodontitis - Bacterial meningitis - Infective endocarditis The Select NA Plus is suitable for processing samples of all groups of people. It is to be used by trained personnel with samples and reagents (diagnostics kits) that are appropriate for the Select NA Plus. The product is intended for professional use.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W02060199ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER

• IVDR Class A medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.