31931RETAL

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 5 countries total.

Trade name

not provided

UDI-DI code

D-6430030990585UL

Basic UDI-DI

B-6430030990585UL

Reference / catalog number

31931RETAL

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

10 test kit. Actim® Partus 1ngeni test is a qualitative immunochromatographic dipstick test for detecting the presence of phosphorylated IGFBP-1 (insulin-like growth factor binding protein-1) in cervical secretions during pregnancy. The test is read using the Actim® 1ngeni instrument. The test is intended for professional use to help predict the risk of preterm or imminent delivery when fetal membranes are intact. A low risk test result (phIGFBP-1 concentration less than 10 µg/l) is a clear indication that the patient is not likely to deliver within 7-14 days.

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