Lepzi PLGF Test

Trade name

Lepzi PLGF Test

UDI-DI code

03800502152019

Basic UDI-DI

B-03800502152019

Reference / catalog number

LD_BG002

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

The Lepzi PLGF Test is a quantitative immunofluorescence in vitro diagnostic assay used with the Lepzi Reader for determination of Placental Growth Factor (PLGF) in EDTA whole blood or plasma. The test is intended as an aid in the diagnosis and prognosis of preterm pre-eclampsia in pregnant women between 20 and 35 weeks’ gestation presenting with signs and symptoms of pre-eclampsia. Intended for professional near-patient use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0102050211PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)

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

• CW007

  Do not use if pouch or packaging is damaged.
• CW009

  Single-use device. Do not re-use.
• CW032

  Do not use after expiration date.
• CW018

  Refer to IFU before use.

No certificate specifically references this device's Basic UDI-DI.