30830ETAC

Organization name

Actim Oy

SRN

FI-MF-000024323

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 11 countries total.

Trade name

not provided

UDI-DI code

D-6430030990455U6

Basic UDI-DI

B-6430030990455U6

Reference / catalog number

30830ETAC

Issuing entity

EUDAMED

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

1 test kit. Actim® PROM test is a visually interpreted, qualitative immunochromatographic dipstick test for detection of amniotic fluid in vaginal secretions during pregnancy. Actim PROM detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

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