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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

GenomEra® SARS-CoV-2 2.0 Assay Kit — IVDD — General IVDD

MD Atlas
Abacus Diagnostica Oy

EUDAMED last updated this device on Aug 24, 2022

GenomEra® SARS-CoV-2 2.0 Assay Kit

B-CDX-150-01-20MP

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Abacus Diagnostica Oy
UDI-DI code: D-CDX-150-01-20MP
Reference / catalog number: CDX-150-01-20

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Manufacturer information

Organization name: Abacus Diagnostica Oy
SRN: FI-MF-000024114
Manufacturer status: Inactive

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Critical warnings

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

CW011
Warnings and precautions listed on the IFU

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: GenomEra® SARS-CoV-2 2.0 Assay Kit
UDI-DI code: D-CDX-150-01-20MP
Basic UDI-DI: B-CDX-150-01-20MP
Reference / catalog number: CDX-150-01-20
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: GenomEra® SARS-CoV-2 2.0 Assay Kit, 20 tests
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105040519CORONAVIRUS - NA REAGENTSInactive

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.