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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

8016; 8018; 8022 — IVDD — General IVDD by PentaBase A/S

MD Atlas
PentaBase A/S

EUDAMED last updated this device on May 25, 2022

8016; 8018; 8022

B-5713915CD002LC9H

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PentaBase A/S
UDI-DI code: D-5713915CD002LC9H
Reference / catalog number: 8016; 8018; 8022

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Manufacturer information

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

Critical warnings

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

CW009
The buffers, primer/probe, and tubes are not to be reused.

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Market distribution

Primary placement in Denmark; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-5713915CD002LC9H
Basic UDI-DI: B-5713915CD002LC9H
Reference / catalog number: 8016; 8018; 8022
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CoviDetect™ FAST COVID-19 Multiplex RT-qPCR Assay is a semi-quantitative RT (Reverse Transcriptase) real-time Polymerase Chain Reaction (PCR) assay intended for the detection of nucleic acids from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. The assay is used with real-time PCR systems. SARS-CoV-2 RNA can be found in the upper or lower respiratory tracts of infected individuals. Samples can be obtained either by nasopharyngeal swabs, oropharyngeal swabs, and/or saliva. Samples can be purified on automated platforms or in manual workflows. The results of the CoviDetect™ FAST COVID-19 Multiplex RT-qPCR Assay may aid in the diagnosis of coronavirus disease 2019 (COVID-19). The assay is provided in a multiplex format analysing three SARS-CoV-2 viral targets and one human target sampling control in the same PCR reaction tube. CoviDetect™ FAST COVID-19 Multiplex RT-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/CD002
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-5713915CD002LC9H

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

EMDN nomenclature code(s)

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

W0105040519CORONAVIRUS - NA REAGENTSInactive

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.