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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

PRIME MDx DNA/RNA Extraction kit… — IVDR Class A IVDR

MD Atlas
A. MENARINI Diagnostics S.r.l.

EUDAMED last updated this device on Feb 6, 2024

PRIME MDx DNA/RNA Extraction kit 2 x48 rxn

8012992PMDXEKYY

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: A. MENARINI Diagnostics S.r.l.
UDI-DI code: 08012992564462
Reference / catalog number: 56446

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View device family (Basic UDI)

Manufacturer information

Organization name: A. MENARINI Diagnostics S.r.l.
SRN: IT-MF-000023427
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.

CW265
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 30, 2024	Still on market

Device identification

Trade name: PRIME MDx DNA/RNA Extraction kit 2 x48 rxn
UDI-DI code: 08012992564462
Basic UDI-DI: 8012992PMDXEKYY
Reference / catalog number: 56446
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 PRIME MDx DNA/RNA Extraction kit, in PreFilled Plate (PFP), has been formulated to isolate viral RNA and DNA, and bacterial DNA from biological samples such as serum, plasma, blood, tissue sample suspensions homogenized, suspensions of stool samples, and swabs
Additional information URL: https://menarinidiagnostics.com/
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

Encoded

(01)08012992564462

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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