PY1210

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095160561

Basic UDI-DI

B-04049095160561

Reference / catalog number

PY1210

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

For in vitro diagnostic use. The RIDA®GENE Factor V kit uses real-time PCR to qualitatively detect a point mutation of G to A at position 1691 in the human factor V gene (Factor V Leiden mutation) in genomic DNA that was isolated from human EDTA whole blood samples. The RIDA®GENE Factor V kit is intended to support the diagnosis in the assessment of patients with suspected thrombophilia.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0106010103FACTOR V LEIDEN

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