Actim® Partus 1ngeni Test

Primary DI

D-6430030990585UL

Basic UDI-DI Code

B-6430030990585UL

Reference

31931RETAL

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Actim Oy

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).