UNIC/GP/010

Organization name

GeneProof a.s.

SRN

CZ-MF-000002370

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 16 countries total.

Trade name

not provided

UDI-DI code

08595696305086

Basic UDI-DI

859569630004Q9

Reference / catalog number

UNIC/GP/010

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The kit is intended for use as an accessory for an in vitro diagnostic medical device. The GeneProof Universal Internal Control presents internal control for the whole diagnostic process, i.e. DNA/RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). Device is intended to be used as a control material without quantitative or qualitative assigned values. The product is intended for use in combination with manual and/or automated extraction from various clinical specimens: whole blood, CSF, plasma, serum, urine, BAL, swab. The GeneProof Universal Internal Control is intended for use as a complementary product for all GeneProof microbiology portfolio kits. The intended users are trained professionals in clinical laboratories and hospitals.

Additional information URL

https://www.geneproof.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• W0105080807MULTICONSTITUENT CONTROLS - INF.IMM.

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• Expiration date
• Manufacturing date
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