Eu-Gen FII/FV Type (25 T)

Organization name

Eurospital Spa

SRN

IT-MF-000028468

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 1 country total.

Trade name

Eu-Gen FII/FV Type (25 T)

UDI-DI code

08028169208404

Basic UDI-DI

802816920CW01060402045C

Reference / catalog number

9462S

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Eu-Gen FII/FV Type kit allows the determination of the presence of the genetic variants Factor II G20210A, or variant c.*97G>A according to new nomenclature (3), and Factor V G1692A, or variant c.1601G>A according to new nomenclature. For Factor II the SNP reference is rs1799963, while for Leiden Factor V the SNP reference is rs6025 which translates to the amino acid substitution Arg506Gln. The method involves a preliminary extraction of DNA from the biological sample under investigation. The DNA is then subjected to a single Real Time PCR amplification reaction specifically for the detection of the genotypes of both targets.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• W0106010115COMBINED FACTOR II / FACTOR V LEIDEN