A58420

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

08595696304270

Basic UDI-DI

B-08595696304270

Reference / catalog number

A58420

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Kit is intended to detect G20210A mutation in the gene for human factor II prothrombin by the real time Polymerase Chain Reaction (PCR). The clinical specimen used for the detection is whole blood. The intended users are professional personnel of clinical laboratories.

Additional information URL

https://thermofisher.com/geneproofIFU

Clinical sizes

No clinical sizes registered for this device.

• W0106010114PROTHROMBIN MUTATION

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