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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

deltaPREP Virus DNA/RNA Kit –… — IVDR Class A IVDR

MD Atlas
IST Innuscreen GmbH

EUDAMED last updated this device on Apr 11, 2024

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (480 rxn) Plates

4262375220038M

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: IST Innuscreen GmbH
UDI-DI code: 04262375223057
Reference / catalog number: 31-DP-4010480

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Manufacturer information

Organization name: IST Innuscreen GmbH
SRN: DE-MF-000024606
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.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (480 rxn) Plates
UDI-DI code: 04262375223057
Basic UDI-DI: 4262375220038M
Reference / catalog number: 31-DP-4010480
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: The novel deltaPREP Virus DNA/RNA Kit - IPC16 is an extraction kit for isolating viral DNA and RNA simultaneously from the same sample. Each Reagent Plate is prefilled and ready to use for 8 samples.
Additional information URL: https://innuscreen.ist-ag.com/products/deltaprep-virus-dnarna-kit-ipc16-mdx
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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