A58119

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 2 countries total.

Trade name

not provided

UDI-DI code

08595696303976

Basic UDI-DI

B-08595696303976

Reference / catalog number

A58119

Issuing entity

GS1

Risk category

IVDD — Annex II List A

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The kit is an in vitro nucleic acid amplification test for qualitative and quantitative diagnostics, aid to diagnosis or monitoring of Human Immunodeficiency Virus type 1 from plasma or serum by the real-time Polymerase Chain Reaction (PCR) method. The kit can be used in combination with a manual or fully automated extraction system. The kit is designed for human in vitro diagnostics. The intended users are professional staff of clinical laboratories. The target population is the EU population.

Additional information URL

https://thermofisher.com/geneproofIFU

Clinical sizes

No clinical sizes registered for this device.

• W0105030107HIV 1 - NA REAGENTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification