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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

GP Reader NT — IVDR Class A IVDR by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Sep 27, 2024

GP Reader NT

6419587RNT0103T

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587343006
Reference / catalog number: 740450

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: GP Reader NT
UDI-DI code: 06419587343006
Basic UDI-DI: 6419587RNT0103T
Reference / catalog number: 740450
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: GP Reader NT is an automated instrument for the quantitative determination of various analytes in human samples, such as whole blood, plasma or fecal samples, by measuring fluorescence signals from lateral flow test cassettes. GP Reader NT is intended for use with compatible fluorimetric lateral flow immunoassay (FLFIA) test kits, such as GastroPanel quick test NT (REF 602410 and REF 602420), as an aid in the diagnosis, screening, or monitoring of medical conditions, as specifically defined, along with the characteristics of the testing population, required specimen, and detected analyte, in the intended purpose of the individual test kit it is used with. GP Reader NT is intended to be used by healthcare professionals, either in a laboratory or near-patient setting. For in vitro diagnostic use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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